Director Medical Resume Samples

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D Larkin
128 Marcelle Fall
San Francisco
+1 (555) 636 8678
128 Marcelle Fall
San Francisco
p +1 (555) 636 8678
Experience Experience
01/2014 present
Boston, MA
Medical Director, Immunology
Boston, MA
Medical Director, Immunology
01/2014 present
Boston, MA
Medical Director, Immunology
01/2014 present
  • Provide technical support and content expertise to medical information and internal and external healthcare providers
  • May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same or related programs
  • May serve on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research
  • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)
  • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents
  • Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents
08/2006 08/2013
Houston, TX
Medical Director, Urology
Houston, TX
Medical Director, Urology
08/2006 08/2013
Houston, TX
Medical Director, Urology
08/2006 08/2013
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Develop post-marketing clinical development plans including the design and management of clinical studies and IITs
  • Continuously review the competitive position of projects and products including competitor actions in order to provide guidance
  • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
  • Contribute medical/scientific expertise in responding to off-label product-based questions and to the objective representation of data, product positioning, on-label promotion, and the legal/medical/regulatory review process
  • May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
  • All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
05/2004 07/2006
Dallas, TX
Global Medical Director
Dallas, TX
Global Medical Director
05/2004 07/2006
Dallas, TX
Global Medical Director
05/2004 07/2006
  • Medical Affairs role for comprehensive healthcare solution engineering design, development, and deployment with large, institutional customers
  • Collaborates to help ensure solution/services have clear identified medical value propositions for patients
  • Establishes healthcare solution protocols and frameworks that accelerate progress across customers
  • Engages and advises the RDMAs and Japan/US Medical Affairs Leads on the integration and execution in their respective regions
  • For ex-US, has medical affairs oversight of patient level data generation activities for the Top Customers Solutions Team, ensuring they are compliant with Merck’s policies for studies. For US, has effective liaison with CORE for data generation
  • The GMD within Customer Centricity (Customer Strategy and Innovation) serves as the authoritative Global Medical Affairs expert for solution-based initiatives co-created with Top Global Customers
  • Leads patient level data generation activities in accordance with Merck’s policies for studies
Education Education
Bachelor’s Degree in Nursing
Bachelor’s Degree in Nursing
Michigan State University
Bachelor’s Degree in Nursing
Skills Skills
  • Completes and administers performance and compensation reviews in a timely, fair and consistent manner and conducts performance evaluation conferences that are constructive and informative, encouraging communication and participation
  • Evaluates and ensures competency of staff as defined by division standards
  • Assists in the development of programs for recruitment, retention, and development as well as oversees relationships with physician recruiters
  • Consistently and fairly applies Human Resources, Hospital and Division policies and procedures
  • Provides training and development opportunities for supervised staff to support an optimal level of practice and professional and personal career growth to enhance job performance and improved operational effectiveness
  • Develops leaders in all aspects of operational management
  • Develops, manages and negotiates physician employment contracts
  • Tracks participation, budget and revenue data, and takes appropriate corrective measures when necessary
  • Works with Revenue Cycle and business team at the local and EMHS level to ensure efficient professional revenue cycle management to include; collection of co-pays, denials tracking, charge description master, timely filing, charge capture, days in A/R
  • Develops, Communicates, and monitors key monthly and quarterly benchmarks as they pertain to assigned medical group management
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Director, Medical Writing Operations Resume Examples & Samples

  • A minimum of 10+ years of experience in the medical/regulatory writing field in a pharmaceutical/biotech industry or CRO environment in positions with increasing levels of responsibility
  • Proficiency at authoring/editing multiple types of clinical regulatory documents across multiple therapeutic/disease areas, QC review of clinical documents, managing document template content and format, and working with electronic document management systems
  • Previous experience managing the medical writing and/or submission activities for multiple original and supplemental licensing applications (NDA, BLA, MAA) or equivalent submissions (IND, End of Phase 2)
  • 3+ years of supervisory experience for multiple direct reports or contract staff in a medical writing group or equivalent. Includes hiring, training, leading, and mentoring staff, setting goals within the function, and managing performance issues. Previous experience developing and overseeing project/department budget and resource allocation

Medical Director Medical Management Resume Examples & Samples

  • Perform concurrent review of facility-based member stays along with the RN Case Managers
  • Conduct facility rounds with the Hospitalist on a regular basis
  • Facilitate designated pre-service reviews for our members
  • Review various analytical and metrics data to ensure quality of care and profitability
  • Work and collaborate with our highly integrated clinics to develop projects for chronic illnesses and population health
  • Serve on Chronic Illness committees as needed with other Optum Local Care Delivery Organizations
  • Active unrestricted MD/DO physician NV license
  • Current board certification or board eligibility
  • 3 or more years of clinical practice experience post residency
  • Strong understanding of evidence-based medicine (EBM) and managed care principles, as well as familiarity with current medical issues and practices
  • Project management or active project participation experience
  • Hands-on utilization &/or quality management experience
  • Mentoring and coaching experience

Director, Medical Cost Initiatives Resume Examples & Samples

  • Utilizing a data-driven approach, solicits and leverages input from within PNS, PNVBS and a broad cross-section of the organization to identify, scope and prioritize opportunities, creating a continuous “pipeline” of proposed initiatives to reduce medical and pharmacy costs
  • Directs an ongoing and comprehensive analysis of medical cost containment efforts attempted by other health plans, provider organizations, ACOs and other government sponsored shared savings programs, supplements information gained through these analyses with input from consultants, vendors, industry publications, through conferences and other relevant sources and leverages this knowledge to further expand the “pipeline” of proposed cost containment initiatives
  • Ensure that key capabilities developed and maintained in support of program goals and objectives. These capabilities include but are not limited to data analysis, process analysis, vendor and ROI evaluations and project management techniques and will be deployed to support a continuous process for assessing and vetting proposed cost containment initiatives; driving credible “go/no go” recommendations regarding these initiatives; and driving the development, planning and execution of approved initiatives
  • Ensures E2E processes related to cost containment activities are coordinated across appropriate stakeholder areas, including Service Operations, CFID, CMC, Actuarial, P&Ls, other areas within PNVBS and outsourced vendor arrangements. Promotes communications among/between these different areas and externally. Identifies potential legal, regulatory, customer/provider risk associated initiatives; works with appropriate counterparts to assess and remediate these risks
  • Oversees active initiatives geared toward achieving current year cost-containment targets via corrections, changes and enhancements to core systems, processes and policies that span multiple internal technological, operational, clinical and financial business areas, including outsourced vendor arrangements. Ensures ongoing monitoring of adherence to project plans and timelines at the initiative and program level
  • Works collaboratively with Actuarial to establish savings targets, monitor progress toward savings goals at initiative and program levels, evaluate/escalate and manage program risks and reports results to senior executives and other key stakeholders
  • Minimum of 5 years management experience in a managed care organization, minimum of 10 years experience in increasingly complex assignments focused on provider relations, provider contracting, provider-related claims operations, preferably with a Blue or national payer
  • Subject matter expert on proven medical cost containment initiatives, previous experience working with medical management (ie Utilization Management, Disease Management, Care Management) teams, audit/claims payment integrity teams, and claims data strongly preferred
  • Proven track record of being able to develop and implement an operating plan or project
  • Demonstrated ability to influence, lead and enact change
  • Demonstrated ability to interact effectively with all levels of the organization
  • Excellent organizational, analytical, interpersonal, written and verbal communication skills

Senior Director, Medical Writing Resume Examples & Samples

  • Line management responsibilities for staff members. Approves courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities and method
  • Manages the medical writing function within the Company; assigns staff to project teams; oversees medical writing projects and ensures agreed to timelines and budgets are met
  • Prepares budgets and timelines for medical writing activities, for full service clinical development projects, and for stand-alone medical writing projects
  • Serves as a member of the department management team for all projects requiring medical writing
  • Acts as an interface between own department and management as well as other departments/BUs and the Company offices
  • Oversees large medical writing projects
  • Trains/informs medical writing personnel in professional skills, administrative issues, and Company policy
  • Writes and reviews proposals for medical writing tasks
  • Leads, together with the management team, the preparation and presentation of large-scale medical writing proposals
  • Oversees the planning, writing, and assembly of documents required for regulatory submissions as needed
  • Participates in the development of protocols, investigator’s brochures, informed consent forms, and other necessary study documents
  • Reviews statistical analysis plans, tables, figures, and listing specifications for grammar, format, and consistency as needed
  • Prepares slides for business development presentations for prospective clients; presents in person or via teleconference at preliminary meetings and/or client bid defense presentations as needed
  • Prepares and reviews manuscripts, abstracts, and presentations
  • Reviews, approves, creates, and revises departmental Standard Operating Procedures (SOPs)
  • Participates in department and/or corporate planning, strategy, budget, profit/loss, and/or development

Cardiovascular Medical Director Resume Examples & Samples

  • Supporting the development, execution and communication of the US Medical Team (USMT) plan
  • Supporting the US Medical Leader in the launch planning process to ensure alignment between medical and brand activities
  • Supporting data generation in the US (including Ph4, HE, Observational, Comparative Effectiveness, big data collaborations, and Non-Client Sponsored Clinical Research (NASCR)) in partnership with Development Operations, Center for Observational Research and Global Health Economics in support of global development and regional strategies
  • Partnering with the Client Therapeutic Area (TA) field-based, Regional Medical Liaisons (RMLs) and HOPE (Health Outcomes and Payer) RML teams to foster and cultivate relationships with external clinical community, including interactions with opinion leaders, payers, P&T committees, IDNs and medical societies for scientific exchange
  • Support the execution of the US advocacy plan in partnership with Scientific Affairs, US Value & Access, and Global Development
  • Ensuring consistency of clinical content and scientific messages across publications and material
  • Attend assigned scientific congresses for the purposes of gaining scientific insights, supporting the communication of information about disease states which may potentially include Client products to congress and meeting attendees, gathering competitive and scientific intelligence, and supporting KOL interactions
  • Collaborate with Client colleagues to support development of publications and other medical communications
  • Engage with assigned cardiovascular cooperative groups to support their scientific and research needs that are consistent with Client Medical Affairs strategy
  • Deliver medical/scientific presentations to internal and external groups
  • Serve as a scientific resource and company representative to patient advocacy groups
  • Build and cultivate relationships with internal cross-functional colleagues, and provide clinical/scientific input, training, and support to internal teams within regulatory guidelines; participate on internal teams as requested by the VP of Clinical Development and Medical Affairs
  • Represent Client at medical and scientific congresses through Medical Affairs' medical information booth coverage and other related activities
  • Serve as a resource to conduct on-going training to the field sales personnel and others, providing up-to-date knowledge of product, uses, and data
  • Completed internship and residency
  • Completed cardiology or endocrinology (lipid focus) fellowship. Internist without subspecialty training will be considered if substantial experience/interest in heart failure or lipids
  • Two or more years of patient care or clinical research experience or basic science research
  • US trained MD or MD, PhD
  • Board Certified/Board Eligible Cardiology or endocrinology (lipid focus)
  • Five (5) or more years of patient care, clinical research experience or basic science research
  • Patient care, academic background, or clinical development experience/medical affairs from a pharmaceutical/biotechnology company or CRO
  • Familiarity with clinical study management and conduct
  • Experience with integrated delivery networks, accountable care organizations, and payors

Cardiovascular Medical Director Resume Examples & Samples

  • Supports the development and implementation of US Medical strategies, including US launch and lifecycle management
  • The focus of the role will be 50-60% internally facing and 40-50% external outreach, and will report to the product U.S. Medical Leader (USML)
  • US trained MD
  • Board Certified/Board Eligible Cardiology

Medical Director Heart Failure Resume Examples & Samples

  • Leverage strong science in the development and launch of commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling strategies in support of successful registration and marketing
  • Medical Affairs and U.S. marketing experience, to include a well-documented history in medical development of cardiovascular and/or critical care therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams
  • Strong leadership and organizational skills; demonstrated personnel management capabilities
  • Ability to travel (U.S. and European; 20-25% annually)

Medical Director, Ophthalmology Resume Examples & Samples

  • Contribute to the development of new indications for existing products
  • Experience in managing clinical trial conduct for Ophthalmology / Retina disorders is essential. Ophthalmology / Retina clinical trial research experience conducted in a pharmaceutical or equivalent environment is strongly desired
  • Medical Affairs and U.S. marketing experience, to include a well-documented history in medical development of ophthalmology therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams
  • Ability to travel (20-25% annually)

Medical Director Neuroscience Resume Examples & Samples

  • Experience in managing clinical trial conduct for critical care disorders is essential. Neuroscience clinical trial research experience conducted in a pharmaceutical or equivalent environment is strongly desired
  • Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities
  • Medical Affairs and U.S. marketing experience, to include a well-documented history in medical development of neuroscience therapeutics and of bridging proactive relationships among product development, clinical development and marketing teams

Group Medical Director Resume Examples & Samples

  • Personally or through a direct report, leads and demonstrates ownership of the design and implementation of clinical development program(s) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’ s customers, markets, business operations and emerging issues
  • Has overall responsibility for leading and mentoring clinical study teams, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned
  • Has primary responsibility for and ownership of design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory briefing packages, submissions, and responses, and other program documents
  • Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, on-boarding, mentoring, training and supporting career development of these individuals
  • May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs) and/or other cross-functional teams and internal stakeholders
  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty (Multiple Sclerosis) in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a sub-specialty fellowship is desirable
  • At least 7 years (9+ years preferred) of clinical trial experience in the pharmaceutical industry
  • Neurologist with MS clinical trial experience and must be able to lead a clinical strategy team, proven ability to run a complex clinical research program independently
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team
  • Must be able to lead and manage through influence
  • Demonstrated commitment to training and development of junior-level staff, using best judgment to assure that they work with an appropriate level of autonomy

Group Medical Director Resume Examples & Samples

  • Manages one level of Medical and Scientific Directors (typically 2 to 4) and/or Clinical Scientists. This responsibility involves direct oversight of clinical development activities and/or management of personnel who may be working on other projects. Responsible for hiring, onboarding, mentoring, training, and supporting career development of these individuals
  • May chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In this capacity, responsibilities may include supervision of matrix team members and serving as the Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs), and/or other cross-functional teams and internal stakeholders
  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment required. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable

Medical Director, Rheumatology Resume Examples & Samples

  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors

Medical Director, Immunology Resume Examples & Samples

  • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables
  • May oversee the work of other staff working on the same or related programs
  • Advanced degree such as a Master's, PhD. is required
  • Ability to provide input and direction to clinical research with appropriate supervision

Medical Director, Urology Resume Examples & Samples

  • Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies
  • May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
  • Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
  • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
  • May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
  • Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance

Director, Medical Operations Resume Examples & Samples

  • Execute tactical deliverables from the Global Medical Strategic Plan e.g. Ad-boards, Symposias and evidence generation activities
  • Make sure all deliverables are done within agreed upon timeframes and budget
  • Lead high level, cross-functional teams across international locations
  • Identify potential risks and develop mitigation plans
  • Effectively communicate with Medical Affairs Leadership and team members
  • Ensure tactical implementation plan is in alignment with corporate business goals
  • Develop Project Management methodology and policies and implement in various locations
  • Demonstrated ability to implement projects of strategic importance
  • 3 years of commercial or project management experience within the biopharma industry
  • 10+ years of industry experience
  • Experience managing global projects with team members in multiple locations; particularly in Commercial
  • Experience managing both internal resources and external contractors/vendors
  • P&L management
  • Demonstrated success in delivering projects on time with client satisfaction
  • Ability to travel up to 20% of the time
  • Strong interpersonal skills; fluent and able to influence others in spoken and written English
  • Exercises foresight and judgment in making complex decisions. Acts independently with good judgement, when needed
  • Analysis and problem solving leadership skills
  • Mastery of Project Management methodology
  • Flexibility, the ability to adapt to changing project scope and direction; particularly as projects require strategic thinking and solutions
  • Ability to professionally interact with all levels of the organization
  • Ability to maintain confidentiality with sensitive information
  • Mastery of Microsoft Project
  • Meeting facilitation

Medical Director, Pharmacovigilance Resume Examples & Samples

  • Chair a regular Safety Management Team for the assigned project(s) or product(s), setting a safety and risk/benefit driven agenda from inception to closure
  • Represent GPV on other project/product team(s) or subteam(s), ensuring processes for timely collection and processing of adverse events, assessment of suspected adverse reactions, and identification of contraindications, precautions, warnings and other risk mitigations, meeting internal and external standards and timelines; and accountable for all GPV deliverables relating to the project/product
  • Lead the detection, validation and management of pre- and/or post-approval safety signals through to resolution
  • Ensures timely, accurate recording of risk management action plans and decisions, and project-manages GPV deliverables as appropriate to ensure completion on time to applicable standards
  • Medical assessment of causality of ICSRs as necessary, including the assessment of quality within the ICSR process
  • Medical evaluation of aggregate safety data, and written contributions to its interpretation, for Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, IB, CCSI, Safety Summaries and Clinical Overviews for the CTD, and other routine and non-routine safety and risk/benefit evaluations for internal or Regulatory purposes as required
  • Provides medical interpretation of complex PV and pharmacoepidemiological data to enable clinical and Regulatory decision-making
  • Identify, initiate and manage to completion, necessary updates to the IB, CCSI and/or local product information, Medication Guide, Patient Leaflet, and other labeling documentation as necessary
  • Medical evaluation of issues arising from PV Operations, such as use of the MedDRA dictionary and the IME list
  • Medical input to ARGUS search criteria as necessary, including development of appropriate searches where no SMQ exists
  • May represent GPV at internal strategic and/or advisory/governance committees,
  • May represent Alexion or act as an external technical resource, for example at DSMB or Regulatory Authority meeting or pharmaceutical industry conference
  • Extensive relevant experience over 8+ years, in drug development, pharmaceutical safety and risk management, signal detection, validation and management, gained in the pharmaceutical industry, or a regulatory or academic environment
  • Leads across teams and across GPV to develop and review complex recommendations to the teams and senior leaders
  • Excellent, independent judgment supported by robust argument, based on leading-edge knowledge and expertise is essential and integral to all elements of the Risk Management Lead, and is the basis of the positive business impact, because the nature of clinical safety data assessment, risk/benefit analysis and risk management planning work is frequently and inherently ambiguous. For example, through foresight and judgment influences the decision to license a product taking into consideration highly complex issues across lines, or anticipates and pre-empts regulators’ reactions to a possible safety signal in a voluminous submission dossier, or selects optimally from a toolbox of risk management methodologies: each independently judged and addressed issue having positive business impact
  • Strong verbal and written communication: identifies, and escalates to team, management and company, and addresses clinical safety and risk/benefit issues that could have negative business impact on a project/product, bringing them to resolution through investigation that can include integrating resource external to GPV (e.g. biometrics, epidemiology, pre-clinical, KOL), while ensuring consistency of actions and decision-making with overall development and/or commercial team strategy
  • Acts independently to represent GPV for technical, resourcing, strategic and operational issues at a team level. Provides (rather than receives) technical, tactical, and strategic direction on GPV deliverables to others in the function, and in the project/product teams
  • Sound problem solving skills: makes decisions by developing innovative options and/or multiple solutions to highly complex problems. Innovative solutions will address risk management problems (e.g. a novel risk minimization program), risk assessment and epidemiologic problems (e.g. the design of an appropriate study), and/or regulatory communication problems (e.g. a persuasive regulatory documentation strategy), that arise during development and/or commercialization. Those solutions have a positive business impact either by reducing investment cost or time, or by minimizing exposure to commercial risk. Recommends courses of action to management and/or senior leaders that impact the discipline, department or line, and influences their decisions
  • Strong personal time-management and project-management skills. Ability to manage multiple overlapping complex tasks to conclusion, sometimes to tight timelines, for several projects and sub-projects, including oversight of others working on those projects

Senior Director, Medical Migraine Resume Examples & Samples

  • Minimum of 5+ years of experience in the pharmaceutical or biotechnology setting preferably within Medical Affairs
  • Neurology or Migraine experience preferred
  • Familiar with statistical tests and interpretation of clinical trial results
  • Ability to understand and effectively communicate scientific / medical of drug products to the medical community

Director, Medical Information Resume Examples & Samples

  • Provide strategic, personnel and budgetary oversight of the U.S. Medical Information department
  • Lead and manage staff, including managers who supervise therapeutic area-aligned teams
  • Develop, coach, and support the professional growth of, individual staff members
  • Create and implement strategic initiatives to improve the efficiency, balance, and quality of work flowing through the department
  • Continuously evaluate the department’s scope of services to ensure the department is maximizing both its collective talent and the value it brings to the organization; make adjustments accordingly
  • Work collaboratively with senior leadership and the therapeutic area leads in Medical Affairs to ensure the department is successfully supporting therapeutic area strategies
  • Work closely with the leaders of other Medical Information departments across the company to ensure the practice of medical information is consistently applied
  • Create, update, or implement policies, SOPs, business practices, and work instructions
  • Develop and implement plans to ensure the structure, scope, support model, and resources of the department are able to meet anticipated changes in workload
  • Contribute to the implementation of new technologies impacting the provision of medical information
  • Analyze departmental metrics so that patterns, trends and issues are identified and shared with senior management and other internal stakeholders
  • Provide leadership for business critical initiatives and projects, as needed
  • Advanced scientific or medical degree (PharmD preferred)
  • Minimum of 15 years of experience in the pharmaceutical industry, with a minimum of 10 years of experience in Medical Information or Medical Communications
  • Demonstrated success in leading a department/functional team and developing individuals
  • Minimum of 10 years line management experience; experience managing people-managers preferred
  • Excellent leadership, interpersonal, and verbal and written communication skills
  • Proven track record in working in a dynamic, cross-functional environment
  • Highly self-motivated and able to perform multiple tasks in a timely fashion
  • Excellent project management, analytical, strategic-thinking, and problem-solving skills
  • Knowledge of applicable regulations regarding the dissemination of medical information, drug promotion and adverse event and product quality complaint reporting
  • 10% travel required

Medical Director Hemato Resume Examples & Samples

  • Provide medical leadership on project teams
  • Provide medical I scientific consultation and therapeutic expertise
  • Oversee study specific medical/safety monitoring activities, ensuring compliance withethical, legal, and regulatory standards as well as ICON and Sponsor SOPs
  • Represent the Medical Affairs Department in business development activities
  • Provide functional/departmental oversight in the absence of Senior Medical Director I Vice President, Medical Affairs
  • Travel (approximately 10%) domestic and/or international
  • Serve as Regional Medical Monitor on assigned projects and as Global Lead Medical Monitor, if requested
  • Ensure provision of al contracted activities and identification of out-of-scope activities onassigned projects
  • Provide medical monitoring for clinical studies
  • Serve as Program Lead Medical Monitor, if requested
  • Provide medical oversight to protocol-related medical and safety issues and communication of medical and safety issues to ICON staff and sponsors
  • Oversee and provide consultation for medical project data reviews, including lab report review, CRF safety review, and other study data
  • Coordinate and provide medical training including therapeutic indication training, protocol training, safety presentations for ICON clinical staff, project teams, or during investigator meetings
  • EMEA Two years (minimum) of industry experience or other equivalent experience
  • Board certification in Hemato-Oncology
  • Ability and willingness to travel approximately 10% of the time or as required

Medical Director Region Resume Examples & Samples

  • Lead, develop and build a high performing, fully integrated Region 3 Medical Affairs Department
  • Manage, coach and develop Medical Affairs personnel (direct and indirect reports)
  • Pharmaceutical Industry experience in a comparable role, ideally with experience of managing teams across geographies
  • Good understanding of healthcare systems
  • Knowledge of the German market is a distinct advantage
  • Strong leadership skills with demonstrable ability to influence at all levels of the organisation as well as with external customers
  • Fluent knowledge of English (spoken and written)
  • Produce timely business management reports, budget tracking and audit data
  • Strong preference for a medical doctor

Medical Director, Global Pharmacovigilance Resume Examples & Samples

  • Training and mentoring of Pharmacovigilance Physicians and Specialists
  • Qualified physician (Licence, e.g. GMC registered, preferred)
  • Good level of computer literacy with Microsoft applications

Medical Director, Immunology Resume Examples & Samples

  • Provide technical support and content expertise to medical information and internal and external healthcare providers
  • Lead efforts for data generation and for the development of data displays
  • Prepare and give presentations for internal training and to external audiences
  • Serve as a clinical and content expert for internal stakeholders
  • Represent UCB at key medical conferences and congresses
  • Provide medical support for key commercial activities
  • Develop a phase IV research program and participate in the review and disposition of investigator initiated studies
  • Establish relationships with external experts and patient advocacy groups
  • Planning medical education programs

Medical Director, Cystic Fibrosis Resume Examples & Samples

  • Represents Vertex to outside medical personal in the development of clinical protocols and study conduct
  • At least 5-8 years of basic or clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
  • Global clinical research experience and experience interacting with regulatory authorities

Medical Director, Technology Resume Examples & Samples

  • Interact with key physician leaders and product owners to assess market research and competitive data and formulate product features and capabilities that provide competitive advantage for Collaborative Care
  • Develop a deep understanding of provider needs in all Local Care business models and formulate product capabilities that would differentiate Optum Local Care Delivery as an employer or partner
  • Provide clinical and physician workflow expertise to the Optum Technology team, particularly during the conceptual development and requirements phases of the product development process
  • Directly manage initiatives and provide executive level reporting that ensures understanding of the disposition for each consumer deliverable and the progress against the overall Product Strategy and Roadmap
  • Contribute to the development of a financial business case that quantifies the consumer value proposition and ROI, working in conjunction with the Software Development & Support Services to obtain technology product cost estimates for each initiative
  • Communicate the overall product technology vision and influence the capital plan with key business stakeholders to ensure that technology product initiatives are effectively prioritized and funded
  • Assess evolving health information technology trends and anticipate changes in direction that necessitate rapid modifications to the Technology Product Strategy so as to effectively manage initiative risks, impacts and priorities
  • Facilitate Enterprise and Domain architectural activities that ensure the future viability, configurability, and positioning of provider-centric products within Optum’s Enterprise or in an external Cloud marketplace
  • Maintain relationships with appropriate technology partners (internal and external) in developing, deploying, and supporting technical solutions for Local Care Delivery
  • Drive and manage product definition, strategy, analysis and go-to-market plan
  • Contribute to and manage the product strategy roadmap which includes managing blueprinting, strategic planning, prototype and product development
  • Physician with M.D. degree or equivalent
  • Experience with direct patient care in an ambulatory setting
  • Extensive experience within a health care provider setting
  • Certification or formal training in Clinical Informatics, Board Certification in Clinical Informatics is preferred
  • Participation in EMR, analytics, practice management
  • Extensive experience with enterprise EHR systems
  • Experience in a capitated payment model
  • Deep understanding of Clinical Quality programs (Medicare Advantage risk adjustment, STARS, HEDIS, etc.)
  • Adept at communicating a technology vision within a large corporate environment ensuring business and technology leaders understand opportunities, risks, and strategic positioning
  • Practical leader capable of creating and implementing plans to achieve strategic objectives
  • Innovative with a broad understanding of technology and future trends and able to identify opportunities which apply technology as a strategic enabler for the business
  • Capable of gaining support for initiatives through influence and use of business rationale
  • 5 plus years post residency experience
  • Experience and knowledge of PLM and agile development

Medical Director, / Correctional Services Resume Examples & Samples

  • Medical administrative in the County of Los Angeles is defined as: planning, organizing, developing, staffing and controlling of a health facility, clinic, ward, or program
  • Experience in the operation of a mental health or substance use disorder treatment services programs in jail or correctional facility
  • Experience in developing and implementing various clinical services
  • Experience in Quality Improvement of clinical services

Program Director Diagnostic Medical Sonography Resume Examples & Samples

  • Directs, designs, and implements the Imaging/Therapy educational program and curriculum, including integration of education strategies region-wide to ensure accreditation requirements and Kaiser Permanente strategic initiatives are met. Manages development of strategic priorities that are aligned with overall Kaiser Permanente organizational goals and initiatives
  • Leads or make significant contributions to high level multi-disciplinary work teams to achieve quality+C35 outcomes. Establishes and implements policies, strategic goals and priorities that contribute to the strategic initiatives of quality
  • Establishes and recommends policies and procedures to assure consistency and quality of education
  • Develops, implements, instructs, and monitors Imaging/Therapy program curriculum and continuing education classes/programs for various levels of audiences
  • Works collaboratively with KPSAHS Administration to maintain program accreditation. Assures interventions and programs comply with regulatory agencies
  • Establishes collaborative relationships with Regional allied health leadership, Medical Centers, affiliated clinical organizations, partners and community to support and provide consultation in curriculum
  • Minimum five (5) years of management or educator experience in a health care setting, including at least two (2) years of experience as an instructor in an accredited JRCERT/JRCNMT/JRCDMS Imaging/Therapy Program and at least three (3) years of full-time work experience in the imaging/therapy discipline
  • Graduate of an accredited school of Imaging/Therapy Program

Medical Bioethics Director Resume Examples & Samples

  • Advisor and co-chair of KP Bioethics committee, directs and expands the KP Bioethics program
  • Responds to individual and organizational cases and issues
  • Conducts individual ethics case reviews and facilitate team consultations
  • Analyzes and improve consultation methods and approaches
  • Reviews policies and development as it relates to patient rights and Bioethics
  • Assures compliance with accreditation and agency standards pertaining to clinical ethics and patient rights
  • Function in Bioethics consultation and education to staff (hospital and medical center), clinical trainees/Fellows/interns, members, professional community and community at large
  • Provides advice, guidance and education regarding end of life care to providers and staff
  • Works with health care providers at the bedside to provide high quality and sensitive consultation to patients and their loved ones
  • Reviews patient medical charts when necessary for adherence to policies of a bioethical nature
  • Represents KP at the Regional Committee on Bioethics and takes on projects at the Southern California Region proportionate to what other co-chairs of KP have done
  • Professional experience in organizational and research ethics is preferred
  • Doctorate in ethics or related field, or M.D., or J.D. preferred

Director of Medical Resume Examples & Samples

  • 3+ years of Medical-Surgical experience
  • Previous Leadership experience
  • Specialty or Board certification

Director Medical Management Resume Examples & Samples

  • Effectively manages the activities of staff providing leadership and guidance
  • Interviews, recommends for hire, and evaluates staff, and counsels and confronts unsatisfactory performance promptly and fairly and administers corrective action
  • Identifies department goals and objectives, develops and communicates action plans through regular staff meetings and other communications, uses team approach to problem solve and sets clear expectations
  • Identifies training needs and develops and participates in staff training. Provides a challenging and supportive environment and delegates appropriately. Seeks additional training opportunities through outside sources
  • Analyzes work plans developed by subordinate managers and monitors the status of their work in relation to the overall schedule requirements
  • Develops monitoring systems and measurements and exhibits a customer service philosophy
  • Manages statistical and qualitative information concerning patient outcomes and physician/hospital practice patterns in accordance with health plans utilization standards
  • Intervenes with hospital or physician contractors to examine cases to ensure methods for meeting these utilization standards while maintaining precedent for quality of case standards
  • Determines and enforces - through functional groups - medical management requirements in accordance with real company needs, based on current regulations and state-of-the art product development
  • Organizes and promotes medical management functions
  • Evaluates and develops improved techniques for the control of quality and reliability
  • Plans and develops improved techniques for the control of health care costs
  • Plans, on a quarterly or longer basis, the overall use of resources
  • Provides information and advice to higher level management related to medical management
  • Must have and maintain current valid and unrestricted Registered Nursing (RN) license
  • Valid state driver's license
  • Five years clinical experience in an acute care setting
  • Four years experience in quality management/improvement in a health care setting
  • Two years work experience in a managed care environment
  • Five years management experience in a health care setting
  • Three years medical management experience in an HMO setting desired

Country Medical Director, J&J Philippines Resume Examples & Samples

  • Leading local and overseas specialists across the business
  • Regional and sub-regional leadership teams
  • Other local management board members
  • Sales and Marketing leaders in local Operating Company
  • Cross-functional colleagues
  • Regulatory Affairs leads
  • Global Clinical Operation team leads
  • Medical Affairs Operation (MAO) leads
  • All Medical Team leaders and members
  • Local Regulatory agencies
  • Local Industry Associations

Division Director of Medical Resume Examples & Samples

  • Executes a plan for education and competency development activities that support the transition from novice to expert in medical, surgical, orthopedic and oncology patient care areas
  • Consults with Parallon Workforce Management Services for onboarding of nurses from the West Florida Division STAR-N program
  • Aligns education and competency programs with standards established by the Academy of Medical-Surgical Nurses (AMSN), the National Association of Orthopedic Nurses (NAON), the Oncology Nursing Society (ONS) and evidence based practice standards
  • Acts as a coach and mentor for preceptors, charge nurses and managers responsible for the care of medical, surgical, orthopedic and oncology patients in the hospital setting
  • Supports nurses seeking and maintaining medical, surgical, orthopedic, oncology or other related area by leading coaching and education activities
  • Develops and delivers continuing education activities for nurses, techs, physicians, and other clinicians working with medical, surgical, orthopedic and oncology patients in a clinical setting
  • Measures outcomes of education and competency development plans including patient experience scores, core measure performance, RN recruitment and retention, etc
  • Licensure / Certification / Registration

Senior Market Medical Director Resume Examples & Samples

  • Quality and Affordability – This medical director has responsibilities for appropriate utilization management from a “macro” view, for example, conducting hospital Joint Operations Committee meetings with Network, contributing to--and implementing--regional Medical Cost Operating Team decisions, data sharing with physicians and physician groups on quality and efficiency improvement opportunities, and implementing local Health Care Affordability Initiatives. Clinical lead for healthcare affordability initiatives at the local market and establishing a process for sharing data with hospitals and physicians and completing peer to peer communications as required. Support UHN initiatives and Quality Affordability Programs as required in order to achieve the appropriate inpatient and outpatient utilization and affordability goals of the Health Plan and United Clinical Services
  • Growth – This medical director delivers the clinical value proposition focused on quality, affordability and service, in support of the sales and growth activities of the Health Plan including conducting Broker/Client presentations and participating in customer consultations. S/he reviews and edits communications materials as required, and represents the voice of the market-based customer in program design. S/he actively promotes positive relations with State/local regulatory authorities and Medical Societies
  • In addition to the responsibilities above the Senior MMD may have responsibilities that include representation on regional or national quality oversight committees, manage a regional or national level project or relationship
  • A Senior MMD could be considered a national SME in a particular area or specialty ie premium designation, clinical profile treatment and patient centered care model
  • Provide national accounts support when appropriate
  • Provide coverage support for Regional Chief Medical Officer to attend meetings when requested
  • Responsible for assisting with the onboarding and training of new medical directors
  • Serve as a public relations contact when requested
  • Ability to manage a team of medical directors or clinical staff
  • Senior clinical executive participates in the development and execution of national clinical strategies and programs, clinical operations, and clinically integrated networks
  • Proven ability to execute and drive improvements against stated goals
  • 10+ years clinical practice experience; strong knowledge of managed care industry
  • Excellent project management skills

Director Medical Alignment, Immuno Resume Examples & Samples

  • Advanced degree in science-related field, such as Pharmacology, Pharmacy, Medicine, or equivalent
  • Leadership abilities
  • Expert technical depth in disease area
  • Strategic influencing skill
  • Excellent project management skill
  • Excellent computer skills (Excel, Word, Power Point, etc.)
  • 3 years managing programs in a team environment
  • Strong knowledge of medical strategy, clinical development, and medical science liaison areas
  • Ability to manage a diverse group of responsibilities
  • Doctorate in Pharmacology, Pharmacy, Medicine, or equivalent
  • Oncology disease experience
  • Minimum 5 years experience in a strategy-setting role within Medical Affair
  • Global experience within the pharmaceutical industry
  • Working knowledge of FDA requirements

Medical Director Hematology Resume Examples & Samples

  • Directs protocol implementation including site identification and communication, attendance at investigators' meetings, correspondence with sites including IRBs and interaction with operations teams
  • Manages program development, including working cross-functionally with all of the disciplines necessary for successful drug development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, marketing, legal, biostatistics and data management, pharmacovigilence, and clinical operations
  • Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies and comprehending biomarker exploration
  • Monitors clinical trials including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
  • Supports data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
  • Supports commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team
  • Interacts closely with Medical Affairs in support of ISTs and publications
  • Interacts closely with the Regulatory group and regulatory agencies, taking part in IND submissions, investigator brochure authorship and communication with US and international regulatory agencies

Director Medical Management Ops Resume Examples & Samples

  • Lead a team of Clinical Operations Consultants and Medical Management Consultants
  • Lead and direct large, complex implementation, performance and process improvement projects, identifying & defining the standard and non-standard requirements with operational performance expectations
  • Oversee installation of new delegations from the pre-delegation review process through implementation and enrollment, including assessment of risks associated with delegation
  • Participates in the development of the business strategy to drive change and/or achieve business objectives during process and performance improvement
  • Support documentation changes and process flows during the delegation process, which may include review of standards & processes with document revisions, as needed that incorporate applicable best practices with proven outcomes for UM, CM, DM, & SNP
  • Monitor and analyze CMS Regulations; provides clinical support to UHN delegation teams, business partners, affiliates, and delegates
  • Provide data and rationale to explain alternative options or processes to improve overall outcomes
  • Manage, support and provide subject matter expertise during internal project initiatives and internal or external audits
  • Ensure relevant training on clinical topics, trends, and processes to various audiences
  • Make and provide determinations regarding future costs for risk assessment
  • Bachelor’s degree in nursing, health care management or other healthcare related field; Master’s degree preferred
  • 5+ years of work experience which includes experience in cross-functional business areas, utilization management, and health care management
  • 5+ years of leadership experience
  • Demonstrated Medicare knowledge & experience
  • Direct experience in clinical model management and capitation/delegation
  • Strong relationship building skills to work with internal and external partners such as Clinical Directors, Medical Directors, Sr. Leadership, business partners and affiliates, and technology partners
  • Strong communication & presentation skills
  • Self-directed with the ability to work independently and with other team members
  • High degree of emotional intelligence
  • Presentation experience preferred

Executive Medical Director Marketed Products & Vaccines Resume Examples & Samples

  • In conjunction with VP Global Safety and other functions within Global Pharmacovigilance will ensure effective functioning of the department including strategic and long-term planning and resource assessments
  • In conjunction with VP Heads Global Safety and relevant PV and extra PV disciplines, including Regional Head of PV will lead and coordinate interpretation of safety data from internal and external studies/sources and communicate at senior leadership level the impact of same both in terms of “go/no go” decisions or modification of development plan or study design, including potential impact on timeline or product labeling
  • Responsible for reviewing, analyzing and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuing scientific and medical implications. Further, coordinating/leading recommendations derived from new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety
  • Leads along with colleagues in allied Safety Functions the development of a global consensus on signal detection tools and activities
  • As one of the most senior physicians in PV Medical Safety will mentors other PV physicians for developmental compounds and market drugs, safety monitoring and risk management assessment and analysis
  • Responsible for presentations to Safety Board and similar forums and will help facilitate cross functional interactions (within and outside Global PV) for same. As appropriate the position holder will directly involve himself/herself in presentations to Safety Board, recognizing that this will primarily reside with the GSL
  • Will ensure that he/she ensures follow up to request from Safety Board
  • Attends corporate committees such as the Therapeutic Area Teams and Development Review Committee representing the assigned therapeutic area(s)
  • In conjunction with Global Risk Management and Pharmacoepidemiology oversee risk management plans for compounds in development and market drugs
  • Ensures that PV physicians are proactively identifying safety concerns and developing contingency strategies that address these challenges
  • Minimum of 10 years experience in pharmacovigilance, clinical research or clinical development, including a minimum of 5 years in a global pharmacovigilance organization. Experience in preparing responses to regulatory agencies on safety-related topics and aggregate analysis of safety data is required
  • Minimum of 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people
  • Demonstrate integrity
  • Work productively in a high pressure environment

Medical Director, Policy Source Resume Examples & Samples

  • M.D. or D.O
  • A minimum of 5 years health plan experience, as Medical Director or Medical Consultant with responsibility for medical policy
  • Demonstrated knowledge and experience evidence-based medicine/clinical research methodology
  • Experience in representing medical policy to consumers, business, providers and media
  • Works effectively with Plan Medical Directors

Medical Director Middle East Resume Examples & Samples

  • Ensures clinical research strategies developed at the Corporate level are adopted and implemented while making efficient use of resources and opportunities locally
  • Provides input and medical support to product strategies developed by BI marketing leads in the region
  • Manages the Medical Department's budget and ensures efficient and effective utlization of resources
  • Operations / Administration

HQ Medical Director Resume Examples & Samples

  • Lead a team responsible for the medical execution of the mature brand portfolio strategy worldwide. This will include
  • Advance scientific degree (MD preferred, PhD, PharmD) with medical, clinical, safety, and/or regulatory experience in various therapeutic areas
  • 5+ years of pharmaceutical experience with good knowledge of drug development and commercialization processes
  • 2+ years of clinical practice or similar preferred
  • Having worked in academia, non-governmental organization, or advocacy is a plus
  • Customer focus and ability to navigate a matrixed organization and multiple cultural diversities
  • High level of negotiation skills and the ability to resolve conflict in a constructive manner
  • Excellent written and verbal communication as well as presentation skills
  • Ability to analyze, interpret, and translate/simplify clinical and nonclinical data
  • Ability to make independent decisions with speed, based on appropriate rationale, grounded in patient safety and access to medicines
  • Demonstrate flexibility, open mindedness and adaptability in a rapidly changing environment
  • Ability to manage multiple projects simultaneously to ensure timely, on-budget, execution of tasks
  • Ability to manage and energize people, and drive a high functioning team
  • Experience in working with external vendors and outsourcing
  • 1604372

Medical Director, Defitelio Resume Examples & Samples

  • Leadership of Regional Medical Affairs for Defitelio
  • Develop and maintain a high level of knowledge of Haematology/Oncology and transplant medicine and related clinical and scientific literature in order to position him/herself as an expert in the field
  • Ensure development and execution of the regional medical affairs strategy and support adaptation and execution in-country through close collaboration and alignment with the country medical affairs teams
  • Responsible for establishing and maintaining internal organizational links with Global/US Medical Affairs, Clinical Development, Regulatory and Global Molecule groups to ensure consistency and coherence of approach and appropriate support for EU/RoW regional projects
  • Ensure development and implementation of the regional medical affairs strategy aligned to commercial growth drivers, including responsibility for regional budget allocation and monitoring
  • Develop strategies and programs to ensure internal and external readiness for new product flow
  • Review and critically appraise clinical and scientific literature to identify key drivers that differentiate Jazz's Haematology/Oncology medicines and provide support and advice to marketing groups in developing strategy and tactical implementation plans
  • Contribute to the development of and maintain awareness of the competitive landscape and communicate intelligence to the marketing team as appropriate
  • Provide guidance regarding appropriate speakers for national/international congresses and workshops in order to expand and enhance scientific exchange
  • Working closely with Regional Defitelio Marketing, ensure the KOL and educational activities are of a high scientific quality and coordinated to meet corporate objectives
  • Support creation of training material and other scientific materials in collaboration with marketing and other appropriate internal stakeholders
  • Support clinical education as well as in-house training for MSLs and hospital specialists and other appropriate staff as required
  • Oversee the development and execution of study plans to provide post marketing data to support the portfolio of Jazz Haematology/Oncology products in phase IV, observational and pharmacoeconomic studies
  • Oversight of the approval and implementation of these projects in line with relevant pharmaceutical regulations and Jazz SOPs as appropriate
  • Maintain a publication plan covering regional data generation. Support communication of product data by development of post-launch publications on a National level based on peer reviewed publications and/or round-table, symposium and meeting outcomes
  • Facilitate and support publication of customer initiated data or reviews in line with Jazz strategy
  • Represent and ensure EU/RoW regional input to global publication planning teams
  • Work with regional and global/US marketing colleagues and selected KOLs in strategic advisory activities
  • Support development of Jazz EU/RoW positioning as the scientific authority on Defitelio and support KOL advocacy through provision of scientific and clinical information via the MSL team
  • Attend appropriate scientific congresses to stay abreast of developments and to support global and regional KOL activities
  • Able to engage and communicate effectively with professionals and colleagues
  • Excellent command of spoken English and preferably at least one other relevant language
  • Strong preference for a Medical Doctor/pharmaceutical physician with Haematology/Oncology experience
  • Strong preference for Medical Degree, PhD or higher science degree
  • Proven track record of excellence in the pharmaceutical industry
  • Must have medical affairs experience including launching new products, market shaping and launch readiness activities
  • Desirable: Experience in establishing strong influential relationships with academic societies

Medical Director, Imaging Resume Examples & Samples

  • Provides strategic and technical input to imaging biomarker development and implementation for both research and early development projects with assigned TA
  • Establishes network of external imaging centers assist team in conducting imaging studies
  • Facilitate a cross functional group of MD and PhD’s and operational staff in order to efficiently and effectively enable the conduct of imaging studies across technological platforms, and geography
  • Build and maintain key stakeholder relationships with translational research into early clinical development (Interface with researchers in DDU, TREC, and TAU teams)
  • Represent Imaging on Global Product Teams (GPTs) and Clinical Sub-Teams (CSTs) to support imaging strategies and implementation plans
  • Provide imaging expertise to early development working groups that support the development and execution of biomarker and personalized medicine strategy and implementation plan
  • Guide discovery scientists in building translation research plans to translate preclinical imaging modalities into clinical research
  • Advises and consults on both preclinical and clinical imaging studies
  • Ensure that clinical imaging biomarkers results support data-driven clinical POC go/no-go decisions
  • Contributes to developing and testing CDx strategy for later stage implementation
  • Evaluate cutting edge novel Imaging technologies
  • Contribute to Imaging group maintaining a state of the art knowledge of clinical, technical and scientific imaging advances and assess these advances for their potential value in lean and efficient clinical studies including Proof of Mechanism and Concept studies
  • Serving as a knowledgeable Takeda representative on imaging issues to external imaging experts, imaging biomarker activities and consortia
  • MD/PhD or MD
  • Knowledge of preclinical imaging science and data to enable 2-way translation to clinic and back
  • Experience in managing teams in the pharma imaging-related context
  • Excellent verbal and written communication skills and interpersonal skills, including presentational capabilities
  • Ability to engage in discussions on imaging biomarkers in innovative drug discovery from early preclinical through to late stage development
  • Experienced in lean clinical development

Senior Director, Medical Writing Resume Examples & Samples

  • Accountable for delivery of clinical medical writing deliverables and objectives across the Alexion portfolio to quality, time and budget
  • Work in close collaboration with Global Development Teams and their leaders to ensure alignment with program objectives. Manage the Clinical Protocol Review Committee
  • Lead, supervise, and manage performance of the global, internal medical writing team across sites including development and succession planning
  • Develop strategies and manage execution of external support for the internal team with Contract Research Organizations (CRO), or other external resources including in various locations globally
  • Develop and manage medical writing resource and budget plans. Manage the functional budget
  • Drive operational excellence of medical writing standards, processes, systems and tools
  • Actively foster a can-do attitude to drive exceptional performance and continuous improvement
  • Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to reporting activities
  • 15+ years of clinical research experience with 5+ years of experience in the development & management of a medical writing function and direct management of staff in a pharmaceutical and/or biotechnology environment. Experience in rare diseases a plus
  • Experience with writing and leading deliverables for global clinical trials and regulatory submissions
  • Experience of direct management of staff in a pharmaceutical and/or biotechnology environment
  • Experience partnering and managing CRO relationships and other external resources a plus
  • Proven excellence in operational strategy and demonstrated ability to execute operationally
  • Excellent communication, planning and organizational skills
  • Ability to inspire, to lead-by-example and motivate the team to seek solutions and get results

Asst / Assoc / Medical Director, ECD Omni Resume Examples & Samples

  • Cross-Functional Team Membership
  • May also, as appropriate, support relevant sub-teams in training new team members
  • Global Clinical Development Planning
  • Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
  • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
  • Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc
  • Participates in CD strategy development
  • May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science development input and guidance. Includes reviewing Phase I protocols and providing CD input into these
  • Supports internal partners in transitioning new drugs/indications into Phase IIIB or publication studies. May review Phase IIIB protocols and other information and provide CD input
  • As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)
  • Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs

Director, Medical Pharmacovigilance Resume Examples & Samples

  • Define, lead and execute the safety strategy within ADTs/ GMATs/ PSTs for smaller products for which he/she is functioning as the PST lead
  • Contributes to the strategy and authorship of key pharmacovigilance documents including but not limited to White papers, regulatory responses, risk management plans and the components of the BRPA
  • Safety Surveillance and Risk Identification and Assessment Risk Management – Apply current regulatory guidance for risk minimization to AbbVie’s product safety, RMP/REMS plans, as appropriate
  • Lead and implement the risk management strategy for assigned products
  • Responsible for the mentorship of colleagues on PST both on product knowledge but additionally on the safety strategy for pharmacovigilance
  • Responsible for execution of surveillance and signal detection for assigned products in collaboration with Aggregate safety and Medical analytics

Medical Director, Rheumatology Resume Examples & Samples

  • Advanced education (e.g., PhD, PharmD, PA, NP) highly preferred. Residency or/+ post doc highly preferred
  • Typically 10+ yrs experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required
  • Management and leadership experience at project level, experience with strategic initiatives/issues
  • Proven leadership skills in a cross-functional team environment. International experience a plus
  • Ability to interact externally and internally to support global business strategy
  • Ability to run a clinical study or medical affairs team independently with little supervision
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
  • Must possess excellent oral and written communication skills

Senior Director, Medical Publications Resume Examples & Samples

  • Lead the development and implementation of our publications planning, processes and execution of our medical publications team. Provide oversight of the Med Info Team and review potential expansion of innovative communications with our stakeholders
  • Oversee and direct development and production of all medical and scientific publications (including meeting abstracts, posters, oral presentations, and journal publications) via collaboration with internal and external stakeholders, as well as oversight of compilation of MedInfo responses
  • Adhere to publications and MedInfo process guidelines
  • Supervise internal team and external agencies for all Publications & MedInfo projects
  • Oversee the writing, review and update of Publication and MedInfo policies and/or standard operating procedures
  • Establish strong working relationships with key internal stakeholders (Medical Affairs product leads/teams, legal, regulatory, clinical, medical writing) and externally (e.g., consultants, advisors, medical thought leaders, partners)
  • Develop and actively manage relationships with journals and publishers
  • Develop and apply industry best practice in publication planning, execution and management
  • Forecast and actively manage the Publications and Med Info budget within the Global Medical Affairs overall budget
  • Manage direct reports and oversee/evaluate Publications and Med Info Team performance
  • Provide regular publication and MedInfo status reports to Global Medical Affairs and other cross functional stakeholders
  • Advanced scientific degree (PhD, PharmD or MD)
  • 8+ years of Publication experience and ideally some background in MedInfo processes
  • Ability to travel (approximately 10-20%)
  • Experience in CF, pulmonology, and/or orphan disease strategy would be desirable
  • Prior experience in the biotech/pharmaceutical industry in Publications or substantial experience on the pharma vendor side supporting publications
  • Strong understanding of all phases of clinical development and collaboration with medical affairs groups
  • Proficient level of understanding in drug development processes and pharmaceutical business
  • Demonstrated experience in leading teams and managing cross-functional groups
  • Ability to write / edit scientific articles, posters, MedInfo responses, and abstracts
  • Demonstrated ability to problem solve and work effectively within complex, matrixed organizations
  • Strong strategic, planning, communication, negotiation, and organizational skills
  • Ability to function with minimal supervision and judgment regarding escalation
  • Embody the Vertex Core Values of Fearless Pursuit of Excellence, Innovation is Our Lifeblood and “We” Wins
  • Ability to navigate and be successful in a fast-paced environment

Medical Director, U.S Resume Examples & Samples

  • Develop, support and provide leadership into near-term and longer-term strategic plans for the Medical Affairs function to support the Corporate objectives
  • Facilitate and execute Corporate communication interface to healthcare professionals and medical associations for dissemination of medical and scientific information about Insmed’s products and therapeutic areas of interest
  • Stay abreast of new developments in clinical paradigms, treatment guidelines, peer-reviewed publications and trends in therapeutic areas of focus for Insmed and serve as a vital internal medical resource for communicating key new development in relevant therapeutic areas of interest and/or development of medical strategies aligned with the evolving marketplace. Synthesize clinical and medical insights into Insmed medical strategic planning
  • Cultivate medical and scientific relationships with the leading key opinion leaders, principal investigators, and key medical groups/associations
  • Serve as medical subject matter expert in the Development Medical Affairs programs, projects and initiatives. Provide support for the development of medical materials, publications, medical education strategy and programming, grants, investigator-initiated research (IIRs), and field medical/medical community engagement. Serve as a clinical subject matter expert in Compassionate Use, MLR and other Medical Affairs processes
  • Requires a Board-certified Physician (M.D. or MD/Ph.D or DO). Specialization in pulmonary or infectious diseases is a plus. Experience in rare pulmonary diseases is desirable
  • Minimum 7 years of experience in biotechnology industry – with experience in medical affairs and clinical development
  • Prior experience in pulmonary disease is strongly preferred
  • Experience in infectious diseases and orphan diseases is a strong plus
  • Must have biotechnology launch experience
  • Demonstrated understanding of US healthcare environment; legal, regulatory and compliance policies and regulation
  • Strategic thinking and highly effective analytic skills
  • Must have excellent communication and presentation skills (verbal and written)
  • Excels in organizational agility and cross-functional approach
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • Travel will be required 20-30%, may include international travel

Global Program Medical Director Resume Examples & Samples

  • ≥ 6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases 2 through 3
  • Advanced knowledge of assigned therapeutic area is desired, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data
  • Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively in compelling presentations
  • Thorough knowledge of GCP, clinical trial design, statistics, and regulatory/clinical development process
  • Demonstrated leadership and management skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment (including remote) in pharmaceutical or biotech industry; ≥ 6 years people management experience required, this may include management in a matrix environment
  • Considerable organizational awareness including significant experience working cross-functionally and in global teams
  • Excellent negotiation and diplomatic skills, experience with submissions and health authorities required

Director, Cardiovascular Field Medical Resume Examples & Samples

  • Inspires excellence in performance and a customer-centric approach to achieve superior results towards department and team objectives
  • Promotes a culture of innovation, constructive challenge, team spirit and accountability founded on ensuring the wellbeing of patients
  • Active participant in developing strategy and objectives for the therapeutic area and specific disease and/or product medical plans based on unmet medical needs and field insights with the Medical matrix functions; leads the development and delivery of the Field Medical activities aligned with these plans
  • Provides clear direction to drive overall execution of the Field Medical activities, and ensures Region Associate Director (RAD) and Medical Science Liaison (MSL) activities are in alignment with US Medical strategies and objectives
  • Ensures team is highly trained and has the skills and capabilities to meet or exceed requirements
  • Presents regular updates to applicable cross-functional stakeholders and/or therapeutic business reviews as requested
  • Attracts, hires, mentors and develops talent
  • Ensures adherence of team with all relevant company policies and procedures, GCP, compliance guidance, BMS Compliance Code of Conduct, relevant FDA regulations, and with legal and ethical standards
  • Participates in Field Medical Leaders Council to support and govern the Field Medical function company-wide
  • Track record of success leading field based teams or other medical affairs personnel is preferred
  • Demonstrated ability to attract, lead, inspire and motivate a diverse and distributed therapeutic team to an overarching company mission and team purpose
  • Knowledge of the relevant disease area a plus
  • Demonstrated ability to build a team and develop a high performing organization
  • Experience developing field programs and metrics aligned with medical activities and objectives
  • Extensive experience working in cross-functional teams and building effective working relationships across a highly matrixed organization
  • Demonstrated ability to leverage field based clinical insights to add value to strategic and tactical initiatives
  • Demonstrated ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner
  • Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills
  • 1604540

Ltss Medical Director Resume Examples & Samples

  • Performs daily review of personal care attendant services to approve or deny appropriate services for members
  • Will work with nursing staff to clarify requests and documentation as needed
  • Responsible for appropriate utilization management including managing / monitoring the results of Care Management / Health services interventions to ensure that utilization goals are achieved including NFLOC, Emod and SDCB reviews, LTSS determinations and trainings
  • Collaborates with Care Management / health services / behavioral health as necessary to maintain focus on achieving targets
  • Participates in healthcare affordability initiatives at the local market
  • Leads the following initiatives
  • MD or DO with an active, unrestricted license in New Mexico
  • 5+ years clinical practice experience, preferably in geriatric medicine
  • Intermediate or higher level of proficiency with managed care

Medical Director Immunology Resume Examples & Samples

  • Experience in the pharmaceutical industry, CRO or equivalent with significant clinical development experience in Phase 2 and 3 (ideally in different therapeutic areas, including immunology relevant therapeutic areas)
  • Experience as medical expert in interactions with regulatory authorities
  • Profound knowledge of clinical development, including regulatory framework
  • Ability to communicate effectively with internal (including senior and executive management) and external key stakeholders (including regulatory authorities)
  • High performer, ability to work independently to solve complex problems and ability to support multiple projects as medical expert, if appropriate
  • Strong data-driven thinking and ability to interpret medical/scientific data and clinical relevance

VP & Medical Director Resume Examples & Samples

  • Plans, organizes, leads and controls activities pertaining to medical review and the subordinate activities within the department (for underwriting and/or claims), to include: planning projects and capital budgets; and training. Develop and administer the department's budget operating effectively at the lowest possible cost. Direct and coordinate short and long range planning to better define internal and external customer requirements
  • Provide professional medical oversight of medical review, utilization review, underwriting review and/or claim review to personnel whom perform medical reviews, utilization analysis of claims and/or underwriting functions. Conduct medical reviews of initial, ongoing, denied, and appealed claims or cases and ensure compliance with accepted medical review standards and medical review requirements
  • Provide professional medical oversight, to include formulation of policy and philosophy, of medical review, underwriting and/or claims activities to support Companies insurance business operations, including a) increase the effectiveness of medical review activities, b) exercise accurate and defensible decision-making on medical reviews, underwriting, and/or claim decisions, c) educate and communicate effectively with underwriters, the provider, supplier, field and wholesaler communities, and d) address situations of fraud, waste, and abuse. Ensure development and consistent application of appropriate medical review policies and procedures as indicated
  • Evaluate and revise, as necessary the effectiveness of medical management protocols and underwriting and/or claims philosophy and guidelines. Understand and apply various management and data analysis tools to increase the effectiveness of medical review payment safeguard activities, including identification of program vulnerabilities
  • Formulate philosophy and guidelines for new product development to facilitate improved risk management. Provide input into the creation and modification of medical underwriting and/or claims policies and procedures. Provide training through lectures/classes for pertinent medical topics as they relate to medical review, underwriting and/or claims
  • Maintain effective business relationships with other medical staff directors in sharing best practices throughout Mutual of Omaha strategic business units. Participate as a member of the Mutual of Omaha medical management staff in all joint meetings, and implement processes by which remote staff can access and leverage home office initiatives and contracts. Provide cross coverage for other Mutual of Omaha Medical Directors as needed
  • Perform last level internal and appeal reviews for all operations and direct consultation with outside experts when necessary as applicable to the medical review and/or underwriting functions. Represent Mutual of Omaha at national and regional medical director meetings, including contractor medical director meetings
  • Medical degree and unrestricted license to practice medicine with seasoned clinical experience
  • Background and experience in internal medicine, family practice or primary care settings
  • Experience in underwriting and claims review experience
  • Effective organizational, planning, analytical and management skills
  • Strong negotiation, communication and human relations skills
  • (Underwriting) background in internal medicine, family practice or general practice is preferred

Director Medical Access Resume Examples & Samples

  • Be a member of the Medical4Patients Steering Committee and Implementation Team
  • Create, execute and deliver Access-related projects on behalf of PDMA
  • Provide expert consultation and best practice sharing to Disease Area Heads and Global Medical Teams Leaders for the inclusion of Access-related strategy and tactics within Global Medical plans
  • Work within global cross-functional teams to build strong business relationships with particular focus on International Payer Strategy Leaders (IPSLs) and Access Evidence Leaders (AELs)
  • Represent Medical Affairs on Roche Access-related initiatives in collaboration with GPMA and GPA
  • Work in collaboration with MORSE group to explore and enhance coordination of resource and expertise with PDMA
  • Provide sustained business ownership of the Medical4Patients (M4P) Toolkit to support implementation

Executive Medical Director, Serm Resume Examples & Samples

  • Establish/enhance robust surveillance and benefit-risk processes based on clinical and scientific expertise to support Seattle Genetics’ products across the lifecycle
  • Management of physicians and scientists in the SERM group including recruitment, training, mentoring and development
  • Establish risk management process starting early in development. Work with clinical teams to develop risk management plans to support Seattle Genetics’ regulatory submissions
  • Oversee signal management and risk management of Seattle Genetics’ products on a global basis across the life cycle
  • Work with clinical counterparts as needed, including review clinical study protocols, development plans and serious adverse event handling
  • Communicate and interact effectively within and across therapeutic teams, and within functional team management as appropriate
  • Provide pharmacovigilance support for internal and external customers
  • Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
  • Work with labeling team to accurately portray the safety profile of assigned drugs or biologics
  • Provide the training, leadership and continuing education for all departmental staff
  • Liaise with clinical/medical counterparts across the business to provide PV expertise as needed
  • Provide input to Pharmacovigilance agreements and interactions
  • Participate in alliance safety teams with external partner(s)
  • Minimum of 3 years (Director) or 5 years (Sr. Dir) in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management
  • Extensive knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS
  • Experience communicating, meeting with FDA, EMA and other global regulatory authorities
  • Excellent teamwork and interpersonal skills are required

Global Medical Director Resume Examples & Samples

  • Leads design and integration of defined prioritized medical initiatives across the Global Medical Affairs Plans with Top Global Customers, reflecting the needs and opportunities of Mutual Areas of Interest for Merck and Customers,
  • Medical Affairs role for comprehensive healthcare solution engineering design, development, and deployment with large, institutional customers
  • Collaborates to help ensure solution/services have clear identified medical value propositions for patients
  • Establishes healthcare solution protocols and frameworks that accelerate progress across customers
  • Helps determine key integration opportunities across HCPs and patients segments of customers appropriately
  • Engages and advises the RDMAs and Japan/US Medical Affairs Leads on the integration and execution in their respective regions
  • For ex-US, scientific communication through contacts, meetings and presentations with/for key stakeholders in accordance with applicable policy and guidance documents. For U.S., no interaction with US scientific leaders unless at advisory board or Expert Input Forum, consistent with applicable policies and guidance documents
  • For ex-US, has medical affairs oversight of patient level data generation activities for the Top Customers Solutions Team, ensuring they are compliant with Merck’s policies for studies. For US, has effective liaison with CORE for data generation
  • MD ID, PhD or PharmD is required; recognized expertise through 5+ yrs clinical and research experience (incl publications) in therapy area is desired
  • Healthcare IT systems expertise and application
  • Strong understanding of customer data (EMR, Rx, Lab,) and data management systems with knowledge of data privacy and security policies
  • Customer engagement experience associated with hospitals, integrated delivery systems and electronic patient records and associated stakeholders
  • Proven ability to effectively communicate information at management level and to external senior customer staff
  • Excellent interpersonal, analytical, communication (written as well as oral), results oriented facilitation and consultative skills to influence decision making

Director / Medical Home / Anson Resume Examples & Samples

  • Acts as a liaison between administration, team members, physicians, and external agencies operating within the Practices
  • Ensures that clinic operations and team members are in compliance with accrediting regulatory agency standards, policies, and procedures defined by CPN and Carolinas HealthCare System
  • Ensures billing and filing of insurance by Medical Group Business Services and Patient Accounting is completed accurately and in accordance with requirements of third party intermediaries
  • Ensures all CPT and ICD-9 coding is complete and accurate in accordance with the American Medical Association's CPT and ICD-9 guidelines
  • Works with Corporate Compliance to educate physicians on all coding changes to ensure coding is in accordance with the above guidelines
  • Ensures the accuracy and completeness of the medical records, including updating of policies and procedures as necessary. Ensures proper handling of medical records in accordance with regulatory requirements and patient information requests
  • Formulates, interprets, and implements management policies
  • Serves in the role of community or public representative for the Practices and is responsible for interfacing with the community served by the Practice
  • Reviews clinic functions and makes recommendations for reduced overhead, cost savings, and enhanced revenue
  • Meets with individual managed care providers to become familiar with plans and to make recommendations to administration

Director, Medical Review Standards Resume Examples & Samples

  • Establish the vision and strategic direction for an integrated team of professionals dedicated to supporting accurate, high quality and compliant medical and commercial communications for AbbVie, and translate department vision for strategic growth and development into team goals for US lines of business
  • Lead a team of medical professionals with responsibltiy for Medical review within Medical Affairs including review of advertising and promotional materials
  • Provide strategy and direction for US Medical Affairs compliance-related policies/processes and quality oversight. Single point of contact and lead US Medical Affairs for initiatives related to compliance and quality
  • Lead the development of processes and standards for the review and approval of medical affairs materials
  • Optimize and align department resourcing to ensure Therapeutic and other business priorities and strategies are approproately covered
  • Lead a cross-functional initiative to oversee and ensure all non-promotional materials, in addition to Medical Affairs materials, are approproately reviewed and documented prior to release from the organization
  • Contribute to cross-functional strategic and tactical brand planning, and oversee analyses and development of medical position and messaging for highly visible pharmaceutical issues and product related developments
  • Negotiate with Commercial, Regulatory, Legal, and Compliance counterparts to make high-risk decisions that have company impact
  • Oversee the development and reporting of metrics and related compliance monitoring for area of accountability. Identify need for process improvements in MR
  • Provide Sr. Leadership consistent and accurate updates on medical review (SWARM) & compliance performance KPIs to mitigate business performance risks
  • Ensure US Medical Affair employees are taking the training necessary to do their jobs through development, maintenance, and reporting of role-based training plans
  • Remain current in GMA related regulations, AbbVie policies, and new regulations affecting GMA to ensure systems, processes, and procedures accurately reflect current global standards

Director of Medical Resume Examples & Samples

  • Enhance oncology services through performance improvement and appropriate utilization of resources
  • Develop an operational system that supports a seamless flow of patients through the continuum of care
  • Collaborate with physicians to provide leadership in the oncology department
  • Evaluates and makes recommendations regarding new technology and services
  • Collaborates proactively with all interdisciplinary team members and with a patient/family focus to facilitate and maximize client healthcare outcomes. Coordinates multi-disciplinary patient care conferences for high risk or medically complex patients
  • Responsible for the planning and coordination of the reporting department activities, the operational efficiency and effectiveness as well as major impact on all other hospital areas
  • Effectively interviews and selects a qualified number of personnel as required to meet department objectives. Ensures hiring practices conform to appropriate Affirmative Action/EEO practices and regulations
  • Provides direction to the staff and supervisors of the Oncology Unit. Reviews performance of the department staff and approves staff evaluations. Responsible for appropriate disciplinary action of staff members as needed
  • Oversees the prioritization of projects and directs resources to ensure the attainment of facility goals
  • Responsible for ensuring reporting departments meet and adheres to all applicable federal, state, JCAHO, and local regulatory agency requirements and for ensuring the department and facilities success in any regulatory survey
  • Confers with other department directors when necessary to resolve procedural difficulties, clarifying department responsibilities, objectives and resolving identified problems
  • Directs, reviews, and analyzes progress and performance of contract services personnel. Makes recommendation on contract initiation, renewals and termination
  • Actively seeks ways to control costs without comprising patient safety, quality of care or the services delivered
  • Demonstrates knowledge of the occurrence reporting system and reports trends in occurrences to staff. This information is used to improve patient safety
  • Ensures staff is educated on established guidelines for reporting a significant medical error or unanticipated outcome in the patient’s care which results in patient harm
  • Associates Nursing Degree required; Bachelors preferred
  • 3-5 years’ experience in cancer related clinical setting preferred
  • 3-5 years progressive management experience required

Medical Director, Rheumatology Resume Examples & Samples

  • Initiates U.S. Medical Affairs activities and generation and dissemination of data supporting overall product scientific and business strategy for Rheumatology
  • Provides scientific/medical education to investigators, clinical monitors, and Global Project Team members related to Rheumatology. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a Rheumatology therapeutic area resource
  • Address complex problems within discipline/project or across disciplines. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Works on problems of diverse scope in which analysis and interpretation of data requires evaluation of multiple factors

Global Program Medical Director Resume Examples & Samples

  • >/=7years pediatric clinical trial experience with demonstrated ability to manage several trials in parallel with multidisciplinary trial teams
  • Demonstrated ability to establish strong scientific partnership with key investigators
  • Advanced knowledge of assigned pediatric therapy area is desired, with the capability to interpret, discuss and present trial or section level data
  • Strong interpersonal skills, influence without authority, organizational agility
  • Ability to resolve issues with minimal supervision and understand when to escalate
  • Excellent scientific writing skills
  • Demonstrated knowledge and application of statistical analysis methodology; can identify trends and interpret/report results effectively

Director, Medical Management Resume Examples & Samples

  • Develop department objectives and organize activities to achieve objectives
  • Evaluate and implement changes to medical service functions and performance in relation to company mission, philosophy objectives and policies
  • Manage budget and forecast for strategic planning and key initiatives
  • Coordinate with operating departments on research and implementation of best practices
  • Responsible for the statistical analysis of utilization data on programs
  • Participate in NCQA, State, and/or other accreditations of the Plan
  • Organize and present new concepts, programs and tools to staff and other plan departments
  • Develop communication plans with external providers such as hospitals and State agencies as required to facilitate plan goals and objectives
  • Coordinate with Medical Director to educate and communicate expectations with providers
  • Bachelor's degree in Nursing, related field, or equivalent experience
  • 7+ years of nursing, quality improvement, and management experience in a healthcare environment, preferably managed care

Medical Director, Medical, Oncology Resume Examples & Samples

  • Two (2) + years of clinical research experience and/or basic science research in Oncology or significant interest in Oncology
  • Five (5) + years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
  • Familiarity with FDA organization, guidelines, and practices
  • Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs

Director, Medical Floor Resume Examples & Samples

  • Current Alabama RN license
  • Minimum one year of clinical experience
  • Minimum one year of management experience
  • Current CPR/BLS certification
  • Current ACLS certification

Director, Medical Writing Resume Examples & Samples

  • Oversee and as needed author/edit clinical development and regulatory submission documents.Reviews deliverables produced by team with consideration for regulatory and quality standards
  • Collaborate with Global Project Teams and their leaders to ensure alignment with program objectives
  • Develop strategies and manage execution of projects supported by Contract Research Organizations (CRO), or other external medical writing consultants/resources
  • Establish and manage creation and maintenance of medical writing Standard Operating Procedures (SOP), business practices, work processes, templates for protocols, clinical study reports, patient narratives and an Insmed style guide
  • Develop and manage medical writing resource and budget plans
  • Uses creative, critical reasoning and judgement to problem solve in a variety of situations, seeking advice from management and others as needed
  • Ensure Quality Control review of documents, such as, protocols, protocol amendments, Clinical Study Reports, Investigator Brochures and documents to be integrated into regulatory submissions
  • An undergraduate degree in science or health care related field is required, and advanced degree (MS, PhD, PharmD) is preferred
  • Minimum of ten years of experience in pharmaceutical regulatory writing and in managing professional staff
  • Expert writing and editorial skills with a high level of AMA style and medical terminology expertise
  • Experience with global ICH, eCTD submissions and other electronic submissions, with an understanding of electronic submissions requirements
  • Demonstrated ability to manage timelines and quality of work using strong organization, communication, meeting facilitation and interpersonal skills in a cross-functional team
  • Proficient in MS Office (Word, Excel, Power Point, Outlook) and electronic document management systems
  • Highly proficient in MS Office (Word, Excel, Power Point, Outlook) and electronic document management systems
  • Required 10-20% travel, some of which will be international in scope
  • Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies

Director, Medical Plans Resume Examples & Samples

  • Creating annual strategy proposals, including plan design and contributions, using an analytical, data driven approach
  • Works with Director, Global Wellness to identify opportunities for wellness strategies globally based on analytical findings
  • Coordinates all U.S. medical plan vendor interaction and activity, continually looking for cost-out opportunities. Leads US vendor integration efforts ensuring appropriate metrics, data flows, contracting and PG’s are in place control health care spend
  • Works closely with director, Benefits Accounting in setting plan design, profit plan, and reconciling monthly forecasts
  • Monitors monthly, quarterly and annual medical spending trend and determines the appropriate cost mitigation strategies
  • Leads monthly medical spend analysis and reporting to senior management
  • With corporate legal, ensures compliance with ERISA, HIPAA and EEOC regulations for all health and welfare programs
  • Responsible for managing a staff of 2, and communicating regularly with senior leadership, including C-level executives
  • At least 10 years of broad-based health and welfare experience, including particular knowledge on plan design, strategy and data analytics
  • Highly analytical problem solver with demonstrated experience in medical trend analysis, claims analysis and medical trend reduction strategies
  • Experience in project management and budgeting
  • Good communications skills, written and verbal
  • Experience with broad-based analytics
  • Bachelor’s degree in mathematics or related field required; Master’s degree and Certified Employee Benefits Specialist (CEBS) designation preferred

Director Medical Oncology / Days Resume Examples & Samples

  • Develops plan, in conjunction with Administrative Director, for capital resource required to maintain quality care in the 3 South Unit
  • Administers and appraises Quality Improvement within the services provided
  • Controls processes related to Human Resources; inclusive of hiring, evaluating, terminating, counseling, coaching and development of the staff
  • Develops, interprets, inspect and review policies and procedures for services provided
  • Responsible for twenty four-hour coverage and problem resolution for 3 South Unit/areas of responsibility

Senior Director, Medical Operations Resume Examples & Samples

  • Requires MD, PhD or PharmD with clinical and public health experience in a medically related field and in resource limited settings; additional advance degree in Public Health is preferred but not required
  • At least 15 years of clinical experience caring for patients with HIV and/or viral hepatitis
  • Experience leading, designing and implementing clinical research/implementation science activities in resource limited settings
  • Extensive publication background in regard to global infectious diseases in resource limited settings
  • Knowledge of health related technology applications that improve data flow, knowledge sharing and effective clinical outcomes in global public health settings
  • Experience with landscape of NGOs, funders, government and IGO processes, relevant to strategic priorities of AOEM
  • Demonstrated ability to work collaboratively within a cross-functional environment with internal and external colleagues, including representatives of academia, research, public health, industry and medical communities
  • Must demonstrate strong skills in formal and informal presentations of scientific and clinical data, possess intellectual strength, analytic skills and high professional standards for all interactions
  • Ability to think strategically and to align medical, public health and business strategies
  • Extensive travel will be required

Global Medical Director Resume Examples & Samples

  • Provide medical expertise for the new product planning group, specifically
  • Advanced degree (M.D., PhD or PharmD)
  • At least three years of experience in the biotech or pharmaceutical industry in Medical Affairs, with experience working with cross-functional in-house and field-based teams
  • Experience in clinical development and/or business development highly preferred
  • Highest integrity and commitment to ethics and scientific standards
  • Expertise in thyroid cancer
  • Experience in patient care
  • Excellent communication and presentation skills with the ability to present scientific data in a credible manner
  • Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena

Global Medical Director Resume Examples & Samples

  • Develop and execute the global medical affairs strategy for fitusiran and patisiran, with specific focus on pre-launch and launch activities
  • Provide medical expertise for medical communication activities and publication plans
  • Establish and maintain strong relationships with experts in the relevant disease areas
  • Organize and lead advisory boards as defined in the medical affairs strategy
  • Bring insights from the field into the internal team
  • Ensure a patient-centric and science-centric approach to development of medical affairs activities
  • Review promotional materials
  • Establish and maintain excellent working relationships and credibility with relevant individuals at Alnylam
  • Liaises with appropriate Regional Medical Directors and other regional personnel to ensure fluid scientific communication, satisfy medical needs to help in medical education, market access and commercial success
  • Defines and respects timelines and budgets
  • Establishes strong network between all team members
  • Ensures internal knowledge on key projects by communicating on activities, key results, project updates; as well as external meetings as close partner to top KOLs,
  • Works closely with Agencies for all activities which are outsourced, together with Purchasing, Controlling, Legal, etc; has responsibility for the financial management of the project including budget planning and preparation of monthly reports,
  • Provides medical input in to Global Marketing, Market Access, Sales, HEOR initiatives/projects
  • Travel required, variable by season but averaging approximately 25%
  • If physician, hematology or neurology board certified/eligible
  • Expertise in hemophilia and/or hATTR

Global Medical Director Resume Examples & Samples

  • Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
  • Partner with KOLs to provide insights on current focused therapeutic area issues and questions
  • Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and tactics
  • Strong knowledge of internal medicine, pulmonary medicine, and/or other relevant speciality. Experience in orphan diseases is a plus
  • Medical Degree (MD) with board certification in relevant specialty
  • Clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
  • Experience in Medical Affairs within the biotechnology or pharmaceutical industry. Experience conducting Phase 4 studies and non-interventional observational studies is an advantage
  • Broad understanding of global Medical, Regulatory and Commercial environments
  • Possess understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers
  • Excellent strategic skills with the ability to influence decisions, both internally and externally
  • Ability to work in a fast-pace and ever-changing environment, as well as the proven track record of working effectively in diverse multi-cultural teams involving multi-functional disciplines

Director Medical Orthopedics Resume Examples & Samples

  • Oversee successful daily department operations to achieve quality improvement, fiscal productivity and patient satisfaction goals/objectives
  • Current Florida Nursing License, graduate from an accredited school of nursing
  • 3-5 years’ full-time management experience in the acute care environment

Director, Medical Control Authority DV Resume Examples & Samples

  • 2 years demonstrated progressive program management experience
  • Five years experience in EMS Medical Control Authority Systems
  • 2 years experience working with Advanced Life Support level services
  • Demonstrated Quality Improvement experience
  • Michigan Health Care Provider licensure

Director, Medical Management Resume Examples & Samples

  • Bachelor's degree in Nursing, Healthcare Administration or related field
  • 7+ years of quality improvement, prior authorization, concurrent review, and case management operations
  • Experience in a managed care setting with emphasis on Medicare
  • Knowledge of Medicare coverage rules and parameters for medical necessity decision making
  • Knowledge of CMS requirements’ for Special Needs Plans (SNP) and NCQA oversight requirements preferred
  • RN License in Wisconsin preferred
  • Certified Professional Coder (CPC) preferred

Director, Medical Group Operations Resume Examples & Samples

  • Completes and administers performance and compensation reviews in a timely, fair and consistent manner and conducts performance evaluation conferences that are constructive and informative, encouraging communication and participation
  • Evaluates and ensures competency of staff as defined by division standards
  • Assists in the development of programs for recruitment, retention, and development as well as oversees relationships with physician recruiters
  • Consistently and fairly applies Human Resources, Hospital and Division policies and procedures
  • Provides training and development opportunities for supervised staff to support an optimal level of practice and professional and personal career growth to enhance job performance and improved operational effectiveness
  • Develops leaders in all aspects of operational management
  • Supports the planning, coordination, implementation and evaluation of educational activities including orientation, in-service education and continuing education to meet regulatory requirements as well as schedules regular documentation and coding audits with follow up education
  • Develops, manages and negotiates physician employment contracts
  • Tracks participation, budget and revenue data, and takes appropriate corrective measures when necessary
  • Works with Revenue Cycle and business team at the local and EMHS level to ensure efficient professional revenue cycle management to include; collection of co-pays, denials tracking, charge description master, timely filing, charge capture, days in A/R
  • Develops, Communicates, and monitors key monthly and quarterly benchmarks as they pertain to assigned medical group management
  • Develops annual operating and capital budget and volume and revenue forecasts based on sound data and utilizing trends and other financial information to enhance budget process with full participation of the individual program
  • Manages finances through monitoring and interpretation of data to assess and improve operations performance
  • Monitors division's actual trends and productivity benchmarks and assures appropriate adjustments are made to expenses and revenue to stay within total budget
  • Utilizes budget data in decision making process
  • Monitors all provider productivity, patient satisfaction and risk management matters; develops, implements and manages provider incentive programs
  • Participates in creating the division's strategic, operational, programmatic and other plans and policies to achieve Mercy's mission and vision
  • Collaborates with other divisions in the development of business plans for new Mercy Hospital programs/services and the expansion of new ones
  • Works in collaboration with the EMHS and MH quality and risk areas on quality and clinical outcomes management, measurement and support
  • Incorporates knowledge of current issues related to the rapid changes in healthcare and issues into the decision making process for current and future programs/divisional changes
  • Proactively coordinates with support sources to resolve operations problems in a timely manner. Reports unresolved problems to VP – MMG
  • Responsible for all purchasing procedures and activities to include the maintenance and replacement of all equipment in their assigned practices
  • As assigned by senior management, participates in the governing body, management, medical staff, and clinical leaders in the organization's decision making structure and processes, including standing committees and multidisciplinary groups as appropriate
  • Attends and actively participates in conferences and community educational programs, professional association meetings, workshops and taskforces; applies acquired knowledge in practice
  • Takes responsibility for determining learning needs and seeks out opportunities for such
  • Demonstrates awareness of changes and advances in field

Director, Medical Resume Examples & Samples

  • Direct medical aspects of regional blood center operations, including the reference laboratories, therapeutic apheresis, stem cell collection and processing, NMDP, research, medical community relations, and collections
  • Provide medical direction for transfusion medicine-related clinical services
  • Provide medical consultations on transfusion medicine issues to regional physicians and other health care professionals
  • Promote the use of safe and effective blood transfusion components and services and enhances the image of the Red Cross as a transfusion medicine leader regionally and nationally
  • Manage the provision of physician services to the regional blood center operations and transfusion related services
  • Serve as a member of the regional blood services senior management team. May function on behalf of the Chief Executive Officer in their absence
  • Active participation in the regional Medical and Technical Advisory Committees or equivalents
  • Interact regularly with external and internal customers
  • Closely interacts with the Donor and Client Support Center in the evaluation of donor and recipient complications, blood product issues, donor re-entries, etc
  • Provide educational opportunities for internal and external customers

Medical Director, Global Pharmacovigilance Resume Examples & Samples

  • Conducts timely medical review of SAE reports and nonserious AE reports occurring during clinical development and postmarketing surveillance
  • Collaborates with and supports the PV Case processing team
  • Prepares, with support from the Medical Director and/or PV Scientist, periodic and ad hoc responses to regulatory authorities
  • Provides input into responses to inquiries from internal sources (such as Medical Affairs, Clinical Affairs and Regulatory), health care professionals, regulatory authorities and other external sources, as appropriate, for questions regarding safety issues of assigned products
  • Assists in the development of information to be incorporated into and updates concerning safety input to the core company data sheet, core company safety information, product labelling, and the investigator's brochure for development products
  • Prepares and presents relevant ICSRs and aggregate data for Safety Management Team (SMT) and Safety Review Team meetings
  • Works with the PV Scientist, case processing team and others as needed, to devise appropriate safety database search strategies to proactively identify new safety issues or to further elucidate suspected safety issues from the medical literature that could impact on the benefit-risk profile of assigned products
  • Provides medical input to detailed reviews of events of interest including those for inclusion in aggregate reports (PSURs, US Periodic/ Annual Reports, ASRs, DSURs, RMPs, REMS) and ad hoc analyses
  • Authors Aggregate Reports (PSURs, Addendum Reports, SBRs, US Periodic/Annual Reports, ASRs, DSURs) and ad hoc Safety Reports, and provides analytical input based on medical knowledge for known and potential risks defined in RMPs and REMS
  • Supports the development of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities
  • Participates in review of clinical study protocol reports and other regulatory documents as necessary
  • Provides support as required for licensing activities, regulatory authority inspections, and for project product recall activities
  • Responsible for management of evolving safety issues for assigned products
  • Supports the education, mentoring and training of safety professionals in GPV and matrix teams on medical and GPV topics
  • MD degree, or equivalent
  • Minimum of 3 years of pharmaceutical/biotechnology industry experience in PV and/or clinical trials safety management/medical monitoring, with emphasis on GPV
  • Experience and ability to engage, manage and deliver successful outcomes with respect to regulatory interactions and inspections, and handling of significant safety concerns
  • Experience in developing adverse event case retrieval and literature strategies for signal detection
  • Strong post-marketing and clinical trial adverse event analysis skills
  • Strong aggregate data analysis and interpretive skills
  • Strong working knowledge of adverse event reporting in Clinical studies
  • Strong working knowledge of US/EU/AP/LA drug safety regulations and ICH guidelines
  • Experience in communicating with the FDA, EMA, and other global health authorities, especially during GPV inspections
  • Understanding and experience supporting the QPPV
  • Working knowledge of MedDRA coding
  • Understanding of pharmacovigilance-related information systems and software tools
  • Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship
  • Knowledge of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny
  • Ability to work effectively in a collaborative, matrix environment
  • High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a “player/coach” as necessary
  • Excellent written and verbal communication skills, strong listening skills and presentation skills, good negotiating and influencing skills
  • Excellent knowledge of and fluency in spoken and written English. Knowledge of other languages helpful
  • Experience with diagnostic imaging agents desirable
  • Medical device experience desirable
  • Available for domestic and international travel as needed

VP & Medical Director Resume Examples & Samples

  • Serves as medical consultant for underwriting of cases from RGA offices globally. Products underwritten will include life and living benefits including critical illness, disability, hospitalization, long term care and impaired annuities
  • Read ECGs and stress test and evaluates medical tests/information
  • Performs mortality and morbidity assessment
  • Performs medical literature research to evaluate cases as needed
  • Provides medical opinion to the claims team to assist in the adjudication of life and living benefit claims including critical illness, terminal illness benefit and disability
  • Provides ongoing education and training for underwriters and claims examiners
  • Writes articles for medical director’s newsletter
  • Assists in underwriting manual development
  • Serves on committees as required by team
  • Acts as medical Subject Matter Expert on special projects
  • Medical Doctorate with a degree from an accredited medical school
  • 7+ years insurance medicine experience underwriting cases
  • Intermediate Word and Excel skills
  • Highly advanced clinical skills
  • Highly advanced knowledge of EKG’s and other tests associated with the underwriting process
  • Highly advanced knowledge of insurance medical practices, trends and research and the ability to apply this knowledge to job and communicate this knowledge to underwriters and management
  • Highly advanced ability to comprehend and interpret insurance and contract documents
  • Exceptional oral and written communication and presentation skills, demonstrating the ability to convey business terminology that is meaningful and well received by all stakeholders, including customers and associates
  • Exceptional ability to communicate across various levels and regions of an organization
  • Advanced knowledge of broad business practices
  • Highly advanced persuasion skills when working with internal partners and external customers to resolve issues/problems
  • Expertise in implementing change, ensuring understanding, participation and ownership
  • Highly advanced investigative, analytical and problem solving skills utilizing experience, research, guidelines and internal resources
  • Exceptional skills in managing multiple tasks, projects simultaneously, including the ability to handle changing priorities
  • Exceptional ability to work well within team
  • Exceptional ability to foster a teamwork and customer service focused environment
  • Amount of travel to be determined based on location of hire

Global Program Medical Director Resume Examples & Samples

  • Accountable for the development, endorsement and execution of the Clinical Development Plan (CDP) for indications in Immunology/Dermatology Disease Area from early to late stages of development adhering to Novartis clinical/data standards of quality for Phase II – III trials. Ensures individual protocols are consistent with CDP and are aligned to achieved the Target Product Profile (TPP)
  • Medical Leader of the Global Clinical Team (GCT); Clinical Development Representative at the Global Program Team (GPT), and Late Phase Development Representative at the clinical/project teams for early development of compounds assigned to the therapeutic area
  • Support the Therapeutic Area Head in leading the peer-review of clinical development plans and protocol synopsis across various indications and programs in Immunology/Dermatology Disease Area
  • Supports the Therapeutic Area Head in driving excellence in clinical trial strategy, design, and execution. This includes CDP, Executable Synopsis (ES), protocol reviews, and development of disease/program clinical standards
  • By working as part of the CDU (Clinical Development Unit) heads clinical interactions with external and internal stakeholder and supports NIBR (Novartis Institute of Biomedical Research)/Translational Medical Sciences especially in driving transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters as needed
  • Accountable for excellence in strategy of clinical development across various indications, design, execution and reporting ensuring high quality data is obtained
  • Responsible for continuous evaluation of drug safety profile, including the aspects of relevance to patients in clinical studies, as well as external stake holders (e.g., health authorities) with support from Drug Safety & Epidemiology
  • Accountable for creation of and for giving critical input to clinical components of key documents (regulatory documents, registration dossiers, value dossiers, pharmacoeconomic dossiers) supporting registration, market access, and commercialization of the compound(s)
  • Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Translational Sciences, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
  • Delivers all relevant components/documents for maintenance of product licenses (e.g., Core Data Sheet generation/revision; clinical benefit-risk assessments for license renewals, responses to Health Authority)
  • Drives scenario development for clinical development to support decision analysis and optimal resource allocation in program. Supports team to manage, forecast, and allocate resources (FTEs and budget) for the clinical program as needed. Accountable for timely execution of clinical deliverables within approved budget
  • Plans and executes publication and clinical communication strategy in coordination with
  • ≥ 6 years of involvement in clinical research or drug

Global Medical Director Resume Examples & Samples

  • US Board Certified or UK GMC Registered Physician status
  • Medical expertise or recent experience within Immunology, Rheumatology or Nephrology clinical development, clinical practice or medical affairs
  • Prior experience within a Medical Affairs, Clinical Development or Rheumatology expert role
  • Rheumatology/Immunology medical affairs and clinical development experienced gained with a pharmaceutical or biotech organisations
  • Experience of working with a Global remit with an understanding of global markets and regulations relating to the development and launch of pharmaceutical products
  • Builds high performing medical networks across the assigned LOCs in collaboration with the Area Medical Directors (reporting to the SVP, Europe, EMAP and Asia Pacific)
  • Engages with senior stakeholders in assigned LOCs to facilitate world class launches, including reviewing and optimising medical affairs tactical plans and sharing learning/ best practice
  • Ensures medical colleagues in assigned LOCs have a robust knowledge of clinical and market access evidence for new products, supporting their preparation for launch – using Franchise-approved materials
  • Resolves issues and removes barriers to successful implementation of global medical affairs strategies and tactical plans in all LOCs in the assigned geography that are not represented on the Franchise Board
  • Partners with assigned LOCs to drive excellence in external engagement with key stakeholders (HCP’s, Patients, Payors and Regulators). Builds strong external networks
  • Coordinates the generation of medical insights across assigned LOCs and integrates/ prioritises these to inform global medical affairs/ evidence generation plans where appropriate (by exception)
  • Facilitates the review and approval of prioritised LOC study concepts (budget <£250k) that are outside the aPIB process on behalf of the RML

Senior Director, Medical Laboratory Based Resume Examples & Samples

  • Oversee the overall operations of the clinical testing function of the laboratory organization. Ensure that laboratory operations meet or exceed all applicable regulatory requirements
  • Ensure that the highest standards of quality and customer service are maintained. Collaborate with Quality Assurance staff on development and implementation of effective programs. Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory. Establish effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures
  • Ensure that laboratory staff are trained on and comply with safety procedures. Establish and implement procedures to ensure that the physical laboratory environment meet safety requirements
  • Participate in the development and implementation of the department's operating budget. Establish standards for cost control and waste reduction. Monitor utilization patterns of services and advise on developing trends in clinical service needs
  • Keep abreast of new technical developments. Implement new tests, equipment, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency
  • Foster a unified culture and facilitate collaboration, coorperation, sharing of information and teamwork. Lead initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention
  • In depth knowledge of clinical testing procedures and applicable laboratory testing regulations
  • Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
  • Knowledge of occupational safety and health rules and regulations
  • Excellent client management and problem resolution skills
  • Excellent financial management skills
  • Effective mentoring and coaching skills
  • Strong operational focus
  • Bachelor's degree in a health sciences field and substantial relevant experience including managing staff; or equivalent combination of education, training and experience

Group Medical Director Resume Examples & Samples

  • Develop the medical vision and strategy for Hematology and Skin Cancer molecules and guide development of the Medical Plans
  • Oversee multiple, in some cases large trials, studies, investigations, other projects and programs for Hematology and Skin Cancer to ensure all activities are completed on time, to high standards and within budget
  • Represent Medical Affairs on multidisciplinary Genentech and Global Roche teams and act as an expert advisor to internal committees, management and teams regarding strategic medical issues and lifecycle planning
  • Act as part of the assigned USMA BioOncology Leadership Team and play a key role in cross-functional planning and decision making
  • Where assigned, serve on Joint Oversight Committees with external partners
  • Lead a team of MDs and Medical Science Directors including recruiting, developing and retaining talent and ensuring a strong succession plan for key positions
  • Develop and lead organizational design, resource requirements, budgets, immediate-medium- and long term capacity for Hematology and Skin Cancer team
  • Oversee and guide the writing of clinical plans and protocols ensuring scientific integrity
  • Provide expert input into review of clinical data for safety and ongoing study conduct
  • Serve as a resource for final interpretation and approval of applicable clinical study data results
  • Participate in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with TAEs
  • Analyze, present and interpret study data, with integrated assessment as compared to published data
  • Foster close collaboration with Drug Safety, Product Development, Pharma Development Medical Affairs (PDMA), Clinical Trial Operations, Regulatory Affairs and Commercial Leaders
  • Compliantly develop and cultivate long-term strategic partnerships with thought leaders and other external stakeholders
  • Act as a guardian for high standards of compliance, ethics and safety; putting patients at the center of all actions

Director, Medical Offices Resume Examples & Samples

  • Works to accomplish the financial and performance objectives of the employed physician offices. Has responsibility for the success of the offices on a day-to-day basis
  • Maintains communication with physicians and office management in the operations of each assigned practice
  • Provides leadership, direction and guidance, coaching and mentoring to office management staff and physicians for whom he or she is responsible
  • Effectively interacts with the SJPN Leadership, hospital department heads and Senior Leadership regarding office activity, operations and initiatives
  • Integral to planning, developing, leading and implementing new initiatives that will be of benefit to SJRMC, SJPN and Trinity Health networks
  • Directly supervises Practice Managers
  • Maintains direct Operational accountability for one practice
  • Develops, in conjunction with medical practice site physicians, implements and evaluates annual practice marketing and physician and healthcare provider promotion plans. Develops, implements and evaluates new or modified patient care or operational support services for assigned medical practice location(s)
  • Develops, implements and evaluates annual operational goals and objectives for assigned medical practice location(s) compatible with network strategic plan and greater Ministry Organization goals and needs
  • Ensures the provision and delivery of cost-effective, high quality, accessible and efficient customer oriented service delivery by physicians and associates of assigned practice location(s)
  • Responsible for the hiring of new clinical and support staff associates for assigned practice location(s) in collaboration with practice physician staff. Assures the completion of all required human resource activities related to hiring, promotion/transfer, corrective action, payroll, associate separation processes and procedures
  • Ensures that newly hired and established associates receive orientation, ongoing training, skills assessment and skills maintenance for clinical, professional, business, technical and computer technology proficiencies. Provides training assessment, ongoing training or training support for associates to ensure knowledge and skills in customer relations, service excellence, safety procedures and patient care protocols
  • Actively ensures patient, customer, physician and associate satisfaction with service delivery or site and organizational work environment. Promotes and fosters a positive organization culture within medical practice location(s) and network. Demonstrates desirable behaviors, values and culture by personal example
  • Directs and controls scheduling of associates and assigns work activities utilizing variable staffing techniques, cross-training methodologies and cost benefit analysis processes. Ensures that work systems, workflow and staffing systems promote timely, efficient and cost effective service delivery and customer satisfaction
  • Monitors, evaluates and audits daily operational and financial activities and assures the integrity of work performed by associates. Responsible for the accuracy and timeliness of patient registration, demographic information and service charge posting, ensuring that daily financial records are accurately maintained and banking transactions completed on a daily basis. Assists, as necessary, in the resolution of billing or collection problems; provides leadership and support to staff, regarding coding, billing procedures, collection processes and other necessary financial and compliance processes
  • Maintains compliance by physicians, healthcare providers and associates with network work standards, policies and procedures and quality and service standards required by external agencies or accreditation bodies
  • Participates in Network and Ministry Organization work groups, committees, task force groups and education/ training activities
  • Duties & responsibilities include accuracy of documenting services and supplies provided to patients, including those that may produce patient charges. If designated as a “Revenue Lead”, additional responsibilities will include revenue reconciliation and charge-error correction as specified by departmental process and hospital policy
  • Manages subordinates in respective department(s). Is responsible for the overall direction, coordination, and evaluation of these department(s). Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
  • Performs other duties and activities as may be assigned

Director, Medical Group Operations Resume Examples & Samples

  • Report to the AVP or VP Medical Group responsible for executing against Medical Group standards across areas of responsibility
  • Understand the application of the NorthShore mission in relation to the Director Role and responsibilities
  • Assume a leadership role in project management and recommend innovative solutions for identified opportunities
  • Lead and develop management team and support physician leadership to achieve overall growth targets for the area
  • Bachelors Degree required; Masters in Health Administration or MBA preferred (or equivalent work experience)
  • Four years work experience for a Bachelors prepared applicant; healthcare setting preferred
  • Two years of management experience for a Bachelors prepared applicant
  • One year work experience for a Masters prepared applicant
  • No previous management experience for a Masters prepared applicant
  • Physician Management experience, Financial management, Operations management and Electronic Medical Record preferred

Director, Medical Group Operations Resume Examples & Samples

  • Lead and develop a management team and support physician leadership to achieve overall growth targets for the supported area
  • Partner with physician leaders and practice management to provide quality data to physicians and staff to communicate quality results and develop plans for improvement
  • Ensure People Management Cycle for physicians and practice management is consistently implemented
  • Masters degree in business or health administration preferred (or equivalent work experience)
  • Four years work experience for a Bachelors prepared applicant, health care setting preferred; two years management experience
  • One year work experience for a Masters prepared applicant, health care setting preferred
  • Previous physician management experience preferred
  • Financial and operations management experience preferred
  • Experience with Electronic Medical Record preferred

Director, Medical & Scientific Affairs Resume Examples & Samples

  • Keep up-to-date with scientific and medical knowledge in own specific area in order to provide relevant expert advice to stakeholders in and out of the company: Attend congresses, workshops, meet with experts and clinicians and screen medical-scientific literature, collect, analyze and summarize information from a scientific and medical standpoint to be able to make recommendations (“Position Paper”), participate in the Post Market Surveillance
  • Determine and sign off on the medical value of potential new product opportunities: Be involved in upfront projects when identifying new opportunities, in collaboration with R&D, Strategy and Marketing. When necessary, organize focus groups with experts and manage advisory boards
  • Help increase the medical and scientific visibility of the company through scientific publications, symposiums or workshops, participation in professional or medical societies or contacts with healthcare authorities
  • Act as medical advisor and point person in validation of the intended use claim of new products, validation of medical content of our communication both internally and externally, assessment of Patient risk analysis and Health Hazard of product defects
  • Initiate or participate in medical training and education (internal and external)
  • Provide medical input to clinical trials: reviewing protocols or data analyses
  • Proactively ensure compliance controls are monitored continually and identified issues are addressed via the proper channels with Compliance/ Legal business partners
  • Degree in health sciences area (E.G. Medical doctor and/or Pharmacist) with relevant experience in the clinical field such as laboratory medicine, applied medicine, clinical trials, healthcare industry,
  • Minimum 4 years of experience (level 6) or 6 years’ experience (level5) leadership and project management experience; Experience working with managed care organizations preferred
  • Good knowledge of hospital/ medical environment , experience in the management and design of clinical trials, ability to lead transversal groups, both internally and externally
  • Skills and Qualifications
  • Proven track record of project management, teamwork, leadership, timely decision making and results orientation
  • Expertise in laws, regulations, and guidelines related scientific communications, as well as industry best practices related to Medical Affairs is preferred
  • Demonstrate high ethical and professional standards with all business contacts
  • Ability to use field-based electronic or other communication tools for all aspects of job
  • This position will require travel of approximately 30%
  • Creative problem-solving skills and decisiveness
  • Spanish and/or Portuguese speaking is a plus
  • Financial Indicators (revenue, budget, etc.): Consulting budget, turnover (1/3)
  • Key Performance Indicators (KPIs): Contacts with leaders and experts (visits, advisory board meetings…), number of publications, posters, size of expert KOL network
  • Key Contacts (internal / external) and Interfaces: (Internal) : R&D, marketing, clinical affairs, …. (External) : Experts, KOL’s and clinicians…

Director, Medical Writing Medical Dermatology Resume Examples & Samples

  • Supervise Medical Writers or managers (direct reports and contract writers) in assigned therapeutic area(s) [TAs]
  • Serve as Medical Writing Lead for designated TA(s) and work closely with the Clinical Leads, Clinical Scientists, other Clinical team members and Submission teams, as applicable, to gather the information (timelines; projects; documents) to forecast and budget resource needs for medical writing deliverables in Global Branded R&D
  • May be responsible to assemble and update the outsourcing budget for resourcing of Medical Writing deliverables across all global branded R&D medical writing TAs, with input from the MW Lead for individual TAs
  • May assume responsibility for contracting, accruals, and approval of invoices of contract medical writing across multiple TAs at the request of the Sr. Director, Medical Writing. Works with support staff to manage budget updates and accruals
  • Recruit and provide input into the hire of new Medical Writing staff. Train new staff and ensure staff adheres to Company systems and standards
  • Conduct employee performance evaluations and provide staff with guidance on technical/project related issues and employee relations
  • Lead the planning and management of the completion of clinical documents in the assigned TA(s)
  • Work in collaboration with management of all stakeholder departments to ensure timely delivery of quality clinical/regulatory documentation
  • May perform as lead writer for key clinical study reports, briefing documents, or other priority clinical documents
  • Perform the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar
  • Supervise and review the work of in house or contracted medical writers for complex clinical documents or CTD summaries, ensuring high quality and adherence to business objectives and Company standards
  • Responsible for quality and adherence to established timelines for all MW deliverables in the designated TA
  • Resolve errors and inconsistencies in clinical data and documentation with appropriate project/study team leaders
  • Adhere to Medical Writing processes for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization
  • Participate as an active leader with clinical project planning /study teams and maintain professional cross-functional interactions with leadership for Medical Writing in project/study meetings
  • Lead process improvement within Medical Writing and cross-functionally to streamline and consolidate processes related to medical writing
  • Assist and support the Senior Director, Medical Writing
  • Perform other activities as requested by company management
  • Contribute to scientific/technical and medical writing reviews of documents (eg, Statistical Analysis Plan) for Biometrics, as needed
  • Update protocol, clinical study report, and global regulatory submission document templates, as needed
  • Author and update standard operating procedures other guidance, as needed
  • Oral and written communication
  • Decision making, demonstrating good judgment, and problem solving
  • Interpersonal relationships, coaching/mentoring, building teams. motivating staff, and influencing at a distance
  • Recruiting and developing staff
  • Taking initiative and demonstrating accountability
  • Directing groups
  • Implementing and ensuring adherence to processes
  • Promoting innovation and process improvement, and managing change
  • Coordinating, assigning, reviewing, and planning assignments for staff or teams
  • Recommending salary actions, transfers/promotions/demotions, discharges
  • Performing staff performance evaluations and participating in performance evaluations
  • Professional leadership ability
  • RPh or RN is a plus
  • Experience with resource planning and budget management is a plus
  • Knowledge of clinical operations, health sciences and biostatistics is a plus
  • Skills with Microsoft PowerPoint, Microsoft Project, Microsoft Visio are a plus

Global Medical Director Resume Examples & Samples

  • M.D. with relevant Transplant experience required
  • Proven medical and scientific expertise in Transplant Medicine required
  • Minimum of 6 years relevant medical- or bio-pharmaceutical Med Affairs industry experience preferred

Medical Director, Medical Operations Resume Examples & Samples

  • Medical decision-making and support for the concurrent review case management registered nurse (RN) team facilitating appropriate use of hospital resources, including safe and timely discharges. These duties will require telephonic physician-to-physician interaction and discussions regarding current hospitalized patients, therefore the Medical Director must feel comfortable in clinical conversations with Blue Shield providers
  • Case review and medical determinations: The Medical Director will review pre- and post-service requests and render decisions based on the Evidence of Coverage, medical necessity, Blue Shield of California medical policy, as well as legal and regulatory requirements. The Medical Director must be conversant with most areas of medicine, show ability for rapid, accurate decision-making, and enjoy care review and the investigation and resolution of complex issues. Experience with CPT coding, medical claims review, hospital billing, and reimbursement is a core competency
  • The Medical Director will participate on projects and committees as necessary
  • Problem analysis and clinical decision-making are most critical skills, including the ability to independently formulate and implement solutions
  • Ability to work independently to achieve objectives and resolve issues in ambiguous circumstances is a must
  • Clear, compelling communicator with demonstrated ability to motivate, guide, influence and lead others including ability to translate detailed analytic analysis and complex materials into compelling communications
  • Ability to work in high-pressure situations while maintaining good leadership and reasoning ability
  • Strong collaborator who can effectively work across an organization to encourage others in planning and execution
  • Listening, interpreting, negotiating and consensus building in bringing business conflict to successful resolution are essential skills
  • Understanding overall managed care organization, business strategies and financial metrics is required. Strong interpersonal and communication skills are needed to effectively interact with employees and clients in a professional and tactful manner
  • Must display ability to lead and to provide training and guidance to others
  • A medical degree (MD or DO) with five or more years of clinical experience (preferably in a managed care setting)
  • Unrestrictive license to practice medicine in the State of California
  • Board certified in a in a recognized medical or surgical specialty (preferably Internal Medicine)
  • More than one year of experience working for a Medical Group, IPA, or Health Plan making decisions for Utilization Management is preferred

Director, Medical Operations Analytics Resume Examples & Samples

  • Responsible for the management of the Medical Operations Analytics team
  • Manage daily, weekly and monthly operational dashboards monitoring critical processes to ensure performance metrics are met and are compliant with regulatory requirements
  • Provide compliance reports in support of DMHC/DOI audit, performance guarantees, client reporting on authorization and case management data
  • Provide in-depth cost of health care analytical support and consultation to MCS clinical teams to enable efficient and effective execution of concurrent review, prior authorization, high-risk and chronic case management, and retrospective claims review programs
  • Identify emerging trends in utilization outcomes and implement process recommendations to optimize clinical program return on investment
  • Partner with internal stakeholders to craft value proposition of clinical programs for Sales/Marketing and inform strategic investment decisions
  • Partner with Medical Solutions & Support and IT to ensure stable analytics infrastructure through data remediation associated with system migrations and implementations of large scale data warehouses
  • Responsible for tracking and performance analysis of vendor-managed programs to ensure compliance with service level agreements and provide data in support of vendor function
  • In partnership with MCS Operational Leaders, develop and implement short and long term strategies to improve team results, reducing administrative expenses, work cross functionally and collaboratively within Health Care Services and with key internal partners to build a high functioning, results oriented environment and organization
  • Partner with internal stakeholders (Claims, Provider Appeals, Grievance and Appeals, IT, Medical Informatics, etc.) to build and maintain collaborative relationships and partnerships. Identify areas of connection to develop end-to-end enterprise-level processes and create added value for Blue Shield
  • Responsible for the development and management of the team budget (~$1.2M)
  • Ensure ongoing staff competency with responsibility for performance evaluations annually and as needed with incident occurrence
  • Strong independent judgment, critical thinking and problem-solving skills required to visualize second- and third-order implications of set direction
  • Ability to anticipate change and deliver in a demanding and constantly changing corporate environment. Demonstrated ability to regularly re-prioritize risks, objectives and action plans based on business need
  • Ability to partner, collaborate with, and influence relevant stakeholders, both internal and external. Strong communication and relationship, and consensus-building skills required
  • Demonstrated ability to coach, mentor, and lead a team through growth and change
  • A minimum of a Bachelor’s degree
  • A minimum of 10 years’ experience including but not limited to statistical analysis, SAS and SQL programming, business intelligence, and care management econometrics
  • Health care operations and analytics experience in the care management domain
  • 5+ years of experience managing professional staff members
  • Experience working with high functioning technical professionals and operational leaders

Director, Medical Services Resume Examples & Samples

  • Must hold or obtain an unrestricted Rhode Island medical license prior to appointment
  • Degree of Doctor of Medicine or Doctor of Osteopathy from an accredited medical school
  • Must be board certified in an appropriate specialty (Family Medicine, Internal Medicine, Pediatrics, and/or Emergency Medicine)as recognized by the American Board of Medical Specialties (ABMS) (certification must be maintained during the tenure as Medical Director)
  • Minimum of six years of current professional clinical experience exclusive of internship and residency practice of medicine
  • Minimum of four years of professional administrative leadership experience
  • Demonstrated supervisory experience in an ambulatory, medical group, and/or healthcare setting
  • Must have a valid DEA registration
  • Demonstrated clinical competency in the delivery of healthcare to late adolescents and young adults
  • Demonstrated strong verbal and interpersonal communication skills
  • Demonstrated group practice primary ambulatory care experience with adolescent/young adult populations, women’s health and/or primary practice orthopedic care
  • Demonstrated ability to work with diverse groups/populations
  • Demonstrated experience in the delivery of primary care, urgent care, and routine office procedures
  • Demonstrated experience with electronic health records/practice management software
  • Demonstrated evidence of collaborative leadership style
  • Demonstrated direct supervisory experience of physicians and advanced practice clinical roles, such as: registered nurse practitioners, physician assistants, and clinical psychiatric nurse practitioners
  • Demonstrated experience serving as a Medical Director
  • Demonstrated experience in physician leadership roles
  • Demonstrated experience accomplishing goals with limited resources
  • Demonstrated experience with the clinical treatment of disordered eating, primary practice orthopedic care and sexual health
  • Accreditation Association for Ambulatory Health Care (AAAHC) or Joint Commission accreditation experience

Senior Director, Medical Pharmacovigilance Resume Examples & Samples

  • Understand assigned products’ pharmacology and chemistry from a safety perspective, relevant nonclinical toxicology and clinical AE profile
  • Develop core knowledge of adverse events commonly associated with pharmaceutical agents- including long QT syndrome, hepatotoxicity, bone marrow toxicity, drug-drug interactions, nephrotoxicity and immunogenicity and expertise in one of these topics. (Expertise demonstrable by ability to serve as internal consultant.)
  • Assist MSE and PV management in developing novel methods for signal detection using aggregate data from clinical trials, post market studies,, epidemiological investigations and literature
  • Evaluate potential safety signals through signal work-up
  • Characterize the signal work-up on safety topics for assigned product requested by internal (AbbVie) and external (e.g., Regulatory agencies, etc.)

Medical Director, Urology Resume Examples & Samples

  • Responsible for leading the clinical development of all US projects in the Urological therapeutic area
  • Support global Urology development projects
  • Provide regular interaction with senior product and clinical management for strategic development issues and marketing operations
  • Clinical Development Plan, Protocol development, Investigator’s Brochure, study execution, medical monitoring, and results interpretation and preparation
  • Clinical lead at external interactions with regulatory agencies
  • Provide technical scientific/medical consultation to the project teams to ensure accuracy and compliance with FPI and FDA standards
  • Maintain a high level of technical expertise through familiarity with medical and scientific literature in the Urology field; establish and enhance relationships with Key Opinion Leaders
  • Manage clinical and non-clinical study data in the context of existing literature and contribute this knowledge to future publications
  • Develop post-marketing clinical development plans including the design and management of clinical studies and IITs
  • Continuously review the competitive position of projects and products including competitor actions in order to provide guidance
  • Contribute medical/scientific expertise in responding to off-label product-based questions and to the objective representation of data, product positioning, on-label promotion, and the legal/medical/regulatory review process
  • Provide input for Business Development projects and early stage project initiation

Medical Director / Medical Leader Resume Examples & Samples

  • Leading the development, execution and communication of the US Medical Team (USMT) plan
  • Collaborating with the US Brand Team in the brand/launch planning process to ensure alignment between medical and brand activities
  • Data generation in the US (including Ph4, HE, Observational, Comparative Effectiveness, and Non-Amgen Sponsored Clinical Research (NASCR)) in partnership with Development Operations, Center for Observational Research and Global Health Economics in support of global development and regional strategies
  • Partnering with the Amgen Therapeutic Area (TA) field-based, Regional Medical Liaisons (RMLs) and HOPE (Health Outcomes and Payer) RML teams to develop and maintain relationships with external clinical community, including interactions with opinion leaders, payers and medical societies for scientific exchange
  • Developing US advocacy plan in partnership with Scientific Affairs, US Value & Access, and Global Development
  • Providing US-focused medical input into global Development strategy, study design and deliverables (eg, protocol, CSR, manuscript)
  • Ensuring consistency of clinical content and scientific messages across publications and materials
  • Reviewing/funding US IME, donation and sponsorship requests, aligned with global strategy
  • Budgeting and forecast accuracy within area of responsibility
  • Coaching, mentoring and developing team members
  • Provide interpretation of clinical study data
  • MD or DO degree from an accredited medical school
  • MD plus accredited fellowship in Oncology, board certified or board eligible
  • Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
  • Knowledge of Good Clinical Practices (GCP), US regulations and guidelines, and applicable US regulatory requirements
  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

Senior Director, Medical Specialty Operations Resume Examples & Samples

  • Develops, implements and monitors the short and long range financial plans for clinic and / or center services for the CPO and health system
  • Reviews and approves fiscal planning proposals for new programs, annual budgets, and long term goals
  • Provides expert financial analysis in order to optimize financial results. Reviews and approves fiscal planning proposals for new programs, annual budgets, and long term goals
  • Provides strategic and operational planning for staffing, fiscal, and material resources. Participates in developing and implementing new systems, policies, programs, and quality improvement plans. Ensures compliance to external regulations and professional standards
  • Plans for short and long term clinic expansion construction needs. Reviews proposals with senior leadership, provides management and coordination of projects, including planned and comprehensive building, landscape, and infrastructure programs
  • Reviews proposals for new technology with senior leadership. Identifies modifications or new systems that integrate and meet current and future needs of the healthcare clinics and/or centers across the organization and/or health system
  • Reviews patient service analytics across the CPO and/or health system clinics. Works with subordinate managers to develop patient satisfaction and workforce culture goals and improve performance for any gap areas
  • Ten (10) or more years of relevant experience
  • Academic health experience

Assistant Director Medical Services Contracting Resume Examples & Samples

  • Manages a group of contract consultants and support staff
  • Defines and researches competitive areas
  • Prioritizes specific services and markets for potential contracting
  • Assists staff with developing strategies for negotiations, resolving issues to move contract negotiations to successful completion, and gaining approvals
  • May be directly involved in negotiations for large/complex contracts
  • Ensures that resulting contracts meet KP strategic goals of access, quality and affordability
  • Maximizes contract leverage using limited number of providers
  • Monitors departmental responsiveness to Medical Center, CSA and Regional clients
  • Oversees the implementation of contracting strategies that support strategic alliances, provider network development in expansion areas, and referrals and claims
  • Manages contracting efforts as they relate to the business development initiative and the sale of KP resources to other managed care organizations
  • Develops and maintains programs and procedures within the department that maintain quality of output, minimize risk, meet audit requirements both internal and external, and promote utilization of affordable providers
  • Provides specific project management for regulatory compliance initiatives (e.g., NCQA Accreditation, The Joint Commission Accreditation, HCFA &MediCal
  • Minimum five (5) years in contracting for health care services and experience analyzing medical expenses and utilization
  • Experience in contract negotiation and management, healthcare reimbursement systems, strategic planning and conflict resolution
  • Additional Preferred Qualifications

Director, Medical Economics Resume Examples & Samples

  • In conjunction with clinical and business leadership, directs and leads analytical processes for the identification, measurement and evaluation of medical expense reduction initiatives
  • Creates monthly key performance indicators for clinical/business owners and senior executive management that identifies opportunities for medical expense savings for the organization. Analytics include focused review of various segmentations of healthcare data including member health risk, provider, market, line of business, and other business segments
  • Facilitates the identification of external benchmark vendors to compare Medical Mutual of Ohio actual results to industry standards looking at external utilization, unit cost and trend information to help develop target performance levels
  • Maximizes use of Medical Mutual of Ohio’s business intelligence tools that support analysis and reporting of population health, provider profiling activities, and line of business product reporting
  • Provide support for value based program modeling and makes recommendations to drive successful contracts that align both Medical Mutual of Ohio and provider quality and cost effectiveness and efficiency goals
  • Responsibility and oversight for analytical processes supporting clinical monthly performance, trend and outlier quarterly reporting
  • Support the yearly budgeting and strategic planning process with key analytics on medial expense saving inputs, trends in cost and membership
  • Bachelor’s degree in Business, Health Care Administration or related field
  • MBA or MHS preferred
  • 8 years progressively responsible managed health care experience with strong background in financial/actuarial analysis
  • 3 – 5 years experience in a progressive leadership capacity
  • Knowledge of insurance and managed care industry
  • Proficient in BI tools (SQL, SAS, MS Office); strong technical skills required
  • Knowledge of actuarial analysis modeling and benchmarking tools

Director Medical Oncology Days Resume Examples & Samples

  • Develops, supervises and administers adult and geriatric services
  • Promotes a multidisciplinary coordination of services, such as, nursing, medical, respiratory care, laboratory, pharmaceutical and public relations
  • Develops monitors, appraises and analyzes budgetary goals and outcomes for 3 South unit
  • Directs, approves, and updates the practice of professional nursing and support positions within the services provided to maintain quality patient care through implementation and evaluation of clinical practice standards
  • Develops, institutes, reviews and implements disaster preparedness policies and procedures for the organization
  • Collaborates, develops and participates in marketing of services, including education program development, external advertising and working in alliance with local and regional programs

Director, Medical Services Resume Examples & Samples

  • Conduct Utilization Management based on Medical Necessity
  • Monitor the Quality of Services provided by the Optum Idaho Network of Providers
  • Conduct Inter - rater evaluation of Peer Review Services
  • Monitor Adverse Benefit Determinations and Provider concerns
  • Provide Clinical Guidance for the development of new services (Intensive Outpatient, Respite, Child and Family Teams etc.)
  • Consult with the Field Care Coordinators
  • Participate in Behavioral Health Consultations, Clinical Case Reviews, and Multidisciplinary Staffing’s when requested
  • Others as assigned
  • Minimum of current Licensed Independent Practitioner (Psychiatric Nurse Practitioner) required
  • Minimum of 5 years operational and clinical experience required
  • Minimum of 3 years of experience working with community based programs and resources designed to aid the Idaho Medicaid population and health care system overall required
  • Demonstrate understanding of relevant medical practice regulations (e.g., State Board Nursing; Medical / Clinical Practice; Board of Pharmacy; Medical Board of Examiners; CMS) required
  • Minimum of 2 years of Leadership experience strongly preferred
  • Demonstrate understanding of managed - care entities (e.g., ACO; CCO; HMO) a plus
  • Demonstrate understanding of state, federal, and private healthcare guidelines, regulations, procedures, and products (e.g., Medicare / Medicaid; HIPAA; MIPAA)
  • Capacity to establish accreditation and audit readiness, monitor efficiency and productivity, and provide internal and external reporting to demonstrate value of care and utilization management for health care commercial or government business
  • Familiarity with NCQA and URAC standards and organized accreditation review for medical programs
  • Knowledge of post - acute care planning such as home care, discharge planning, case management, and disease management