Director Medical Resume Samples

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D Larkin

Darron

Larkin

128 Marcelle Fall

San Francisco

+1 (555) 636 8678

128 Marcelle Fall

San Francisco

Phone

p +1 (555) 636 8678

Experience Experience

Dallas, TX

Global Medical Director

Dallas, TX

Wunsch, Eichmann and Kirlin

Dallas, TX

Global Medical Director

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

Houston, TX

Medical Director, Urology

Houston, TX

Christiansen LLC

Houston, TX

Medical Director, Urology

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

present

Boston, MA

Medical Director, Immunology

Boston, MA

Denesik-Schulist

present

Boston, MA

Medical Director, Immunology

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

Education Education

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

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