Medical Lead Resume Samples

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BD
B Denesik
Bailee
Denesik
391 Klein Center
Houston
TX
+1 (555) 981 3516
391 Klein Center
Houston
TX
Phone
p +1 (555) 981 3516
Experience Experience
New York, NY
Global Medical Lead
New York, NY
Conn-Steuber
New York, NY
Global Medical Lead
  • Planning, designing and managing global and overseeing regional/local medical Advisory Boards
  • Planning, designing and managing global medical Advisory Boards
  • Work with GMTL on defining and implementing GMA strategy and prelaunch plans
  • Serving as Global Medical representative on standing and project-based cross-functional teams
  • Providing physician leadership for scientific communications, including standard responses and publications
  • Conducting medical review and approval of promotional and meeting materials
  • As directed by the GMTL, develop, conduct, or participate in therapeutic training programs for Shire internal departments
Chicago, IL
Country Medical Lead
Chicago, IL
Ratke, Pollich and Gislason
Chicago, IL
Country Medical Lead
  • Under guidance of Country Medical Director and per GMA standards, evaluate MSL and Homecare manager performance and provide constructive feedback
  • Define key performance indicators and metrics to track progress against the activity plans
  • Supporting development and implementation of Country Medical Brand Plans in focus disease areas in the country/ cluster
  • Supporting development and implementation of Country Medical Brand Plans in focus disease areas
  • Maintain KOL plans and timely, accurately and compliantly update medical customer relationship management system
  • Develop and implement Global Medical Plans in focus disease areas at the country level
  • Support the Country Medical Director with development and implementation of Global Medical Plans in focus disease areas at a country level
present
Philadelphia, PA
Country Medical Lead Ophthalmology UK
Philadelphia, PA
Gusikowski-Treutel
present
Philadelphia, PA
Country Medical Lead Ophthalmology UK
present
  • Under guidance of Country Medical Director and per GMA standards, evaluate MSL performance and provide constructive feedback
  • Track and record training activities per established SOPs
  • Develop/increase personal and team knowledge of medical literature and critical appraisal of scientific publications
  • Define key performance indicators and metrics to track progress against the activity plan
  • 20% of time: Manage the disease area Medical Science Liaison team
  • Manage the disease area Medical Science Liaison team, including managing definition and implementation of field activity plans
  • Provide medical support to Shire’s clinical research programs and registries
Education Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
California State University, Fullerton
Bachelor’s Degree in Life Sciences
Skills Skills
  • Establishes highly credible relationships and has personal impact through engaging respectfully and professionally
  • Strong ability to partner and collaborate appropriately with Commercial functions
  • Good people management skills with demonstrated ability to set goals and objectives, and establish and recalibrate priorities
  • Able to expertly manage challenging conversations and handle objections
  • Able to effectively lead and participate in multidisciplinary and virtual teams
  • Able to skillfully manage challenging conversations and handle objections
  • Ability to partner and collaborate appropriately with Commercial functions
  • Excellent written and verbal communication skills
  • Able to expertly exchange scientific ideas and information openly and effectively with key opinion leaders and with colleagues
  • Able to identify and develop target competencies (integrity, openness, competence, consistency, loyalty) in one’s self and the team
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15 Medical Lead resume templates

1

Pharmacovigilance & Risk Management Medical Lead Md Resume Examples & Samples

  • Oversee, prepare, and review responses to ad hoc regulatory queries, and signaling topic reports
  • Support the Qualified Person for Pharmacovigilance in the EEA relative to issues related to assigned products
  • Post-graduate training in a clinical discipline subspecialty preferred, hands-on clinical practice experience desirable
2

Global Medical Lead Hae-director Resume Examples & Samples

  • 10% - Support definition of global medical strategy and plans
  • 60% - Work with GMTL on in-year implementation of global medical strategy As delegated by the GMTL, directly implement in plans in the US and/or guide International in-year implementation of medical strategy, potentially including
  • Planning, designing and managing global and overseeing regional/local medical Advisory Boards
  • Managing design and execution of clinical studies (phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
  • Managing completion of regulatory obligations
  • Monitoring and communicating progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements
  • Conducting medical review and approval of promotional and meeting materials
  • 20% - Interaction with external stakeholders in alignment with customer needs and medical strategy
  • Represent Medical Affairs at internal and external meetings
  • 10% - Maintenance of knowledge base
3

Pharmacovigilance & Risk Management Medical Lead Md Resume Examples & Samples

  • Lead the development and execution of risk management strategies and author internal risk tracking plans and risk management/pharmacovigilance plans for submission to global health authorities for assigned products
  • Assist the VP in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within Shire R&D, and as part of the Global PV & RM organization
  • Postgraduate training in a subspecialty preferred, hands-on clinical practice experience desirable
4

Country Medical Lead-benelux Resume Examples & Samples

  • Systematically leading identification of the scientific exchange needs of Key Opinion Leaders, investigators and other stakeholders in patient care, establishing strong professional relationships and providing credible scientific expertise
  • Leading the design and implementation of best-in-class scientific programs with external KOLs, investigators and Global Medical Affairs and Global Clinical partners
  • Responding effectively to requests for scientific exchange
5

Pharmacovigilance & Risk Management Medical Lead Resume Examples & Samples

  • Medically review individual case safety reports from all sources for assigned products
  • Oversee, prepare and review scheduled Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Agencies)
  • 5% (As Required)
  • Contribute to execution of risk management strategies and author internal risk management plans and risk management/ pharmacovigilance plans for submission to global health authorities, as required
  • Medical Degree required
6

Pharmacovigilance & Risk Management Medical Lead-director Resume Examples & Samples

  • Oversee investigational and postmarketing regulatory reporting and pharmacovigilance activities for assigned products
  • Lead the development and execution of risk management strategies and author internal risk management plans and risk management/pharmacovigilance plans for submission to global health authorities, as required
  • Assist the Medical Surveillance and Risk Management VP in developing and maintaining state-of-the-art pharmacovigilance processes and procedures within R&D, and as part of the Global PV & RM organization
  • Will generally have at least 5 years of pharmaceutical industry experience, within a relevant department (e.g. clinical development, drug safety, medical affairs), including at least 3 years of Pharmacovigilance experience
7

Pharmacovigilance & Risk Management Medical Lead-senior Director Resume Examples & Samples

  • Oversee, prepare, and review Periodic/Annual Reports (FDA) and Periodic Safety Update Reports and other Benefit/Risk Update Reports (FDA and Global Regulatory Authorities)
  • Lead pharmacovigilance activities as a member of drug development project teams; co-lead Safety Review Teams
  • Lead safety-labeling activities for assigned products
8

Pvrm Medical Lead Resume Examples & Samples

  • Contribute to execution of risk management strategies and author internal risk management plans and risk management/ pharmacovigilance plans for submission to global health authorities
  • Hands-on clinical practice experience desirable
  • Will generally have at least 3 years of pharmaceutical industry experience, within a relevant department (e.g. clinical development, drug safety, medical affairs), including at least 1 year of Pharmacovigilance experience
9

Global Medical Lead-lifitegrast Resume Examples & Samples

  • Work with the GMTL and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy. Included is lifitegrast pre- and post launch planning/strategy
  • As delegated by the GMTL, lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
  • 40% - Work with GMTL on in-year implementation of global medical strategy
  • As directed by the GMTL, develop, conduct, or participate in therapeutic training programs for Shire internal departments
  • Board certification in ophthalmology is preferred or at least 4 years experience working in industry on an ophthalmology product
  • Experience in the disease area of interest through clinical experience, biopharmaceutical experience or education is required
10

Global Medical Lead Short Bowel Syndrome Resume Examples & Samples

  • 10% Support definition of global medical strategy and plans
  • Work with the GMTL and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific
  • Develop and maintain knowledge of global pharmaceutical regulations,
11

Global Medical Lead Resume Examples & Samples

  • Work with the GMTL and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • As delegated by the GMTL, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
  • 40% Work with GMTL on in-year implementation of global medical strategy
  • An MD, PharmD, or PhD is required
12

Country Medical Lead-rd-brazil SP Resume Examples & Samples

  • In conjunction with Associate Medical Affairs Director, marketing and other managers, develop the Brazilian KOL strategy, then establish and maintain professional, peer-type relationships with key opinion leaders (KOLs) and other key customers in each of the therapeutic Areas
  • In conjunction with Associate Medical Affairs Director, develop and execute a publication plan to support key marketing strategies
  • Provide medical input to Brazil sales and marketing strategies
  • Review and approval of the medical aspects of Brazil promotional and other materials
  • Genetic Specilization degree
  • Desirable 2 years of experience in Medical Affairs in the Pharma/Biotech industry
  • English Advanced and Portuguese Fluent
13

Country Medical Lead-south Cone Resume Examples & Samples

  • Manage Medical Affairs related to a disease/product or group of products, in the area of the Argentina and South Latin America (SoLA)
  • In conjunction with Medical Affairs Director, marketing and other managers, develop the Argentinean / SoLA KOL strategy, then establish and maintain professional, peer-type relationships with key opinion leaders (KOLs) and other key customers in each of the therapeutic Areas
  • Provide professional leadership for the medical/scientific aspects of Shire HGT Argentina/SoLA symposia, workshops, satellite symposia and other meetings, including speaker contacts, and post-conference publications
  • In conjunction with Medical Affairs Director, marketing, develop and execute a publication plan to support key marketing strategies
  • Where appropriate, contribute to the design of Shire HGT sponsored Phase IIIb and Phase IV clinical trials consistent with the marketing strategy and publication plans
  • Provide medical input to Argentinean/SoLA sales and marketing strategies
  • Review and approval of the medical aspects of Argentinean/SoLA promotional and other materials
  • Assist with the training of Shire HGT personnel on Medical aspects of the business
  • Implementation of and medical approval for appropriate compassionate use programmes
  • Provide medical support on shire’s products for hospital and home infusions programs to medical and HCP teams when deemed necessary
  • Afford local support in the medical handling of safety issues when requested
  • A Medical Doctor with a minimum of 3 years experience in Argentinean Medical Affairs in the Pharma/Biotech industry
  • Fluence in English and Spanish
14

Director, Global Medical Lead-neuroscience Resume Examples & Samples

  • Drive global execution of specific medical projects per global medical strategy
  • Serve as Global Medical representative on standing and project-based cross-functional teams
  • As needed, provide Medical review to Global promotional and non-promotional materials
  • 40%: Work with Global Medical Team leader on in-year implementation of global medical strategy as delegated by the Global Medical Team leader, directly implement in plans in the US and/or guide International in-year implementation of medical strategy, potentially including
  • 30%: Interaction with external stakeholders in alignment with customer needs and medical strategy
  • Present data on product / disease area
  • 10%: Maintenance of knowledge base
  • A MD, PhD and/or PharmD is required
  • >5 years of experience in bio-pharmaceutical medicine, preferably within a matrix or franchise structure
  • Experience in the disease area of interest through clinical experience, bio-pharmaceutical experience or education is preferred
15

Global Medical Lead Pipeline Resume Examples & Samples

  • Work with the Global Medical Affairs Head, Pipeline, to develop and execute multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance) in accordance with the Pipeline Operating Model (POM)
  • Work with the Global Medical Affairs Head, Pipeline, on the development and in-year implementation of the medical plan in accordance with the POM. Head the Pipeline Medical Team (PMT) for the product
  • Serve as Global Medical representative on standing and project-based cross-functional teams (EDTs where applicable, GDTs, ECTs etc)
  • As needed, provide Medical review to New Product (Commercial) non-promotional materials
  • Work with the GMA Head, Pipeline and Pipeline Medical Team (PMT) to develop medical strategy, including e.g. Pipeline R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy and in accordance with the POM
  • Support development of the in-year medical tactical plan and budget for global initiatives and the United States
  • As delegated by the GMA Head, Pipeline, lead functional (e.g. publications, medical communications, medical training) and Pipeline R&D teams in developing plans supporting global medical strategy
  • As delegated by the GMA Head Pipeline, collaborate with New Products to ensure aligned and medically appropriate commercial strategy, planning and execution
  • As delegated by the GMA Head Pipeline, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Global Development Teams and Early Development Teams where appropriate
  • 40%: Work with GMA Head, Pipeline on in-year implementation of global medical strategy
  • >5 years of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure
  • Experience in clinical development is preferred
16

Associate Director, Global Medical Lead Resume Examples & Samples

  • Work with the Global Medical Team leader , neuroscience to develop and execute multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
  • Work with the Global Medical Team leader, neuroscience on the development and in-year implementation of the medical plan in the US and/or support in-year plan definition and implementation by International Medical Affairs
  • 20%: Support definition of global medical strategy and plans
  • Support development of the in-year medical tactical plan and budget for the global initiatives and the United States
  • As delegated by the Global Medical Team leader, lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
  • As delegated by the Global Medical Team leader, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution
  • 40%: Work with Global Medical Team leader on in-year implementation of global medical strategy
17

Country Medical Lead-uk-lsd / HAE Resume Examples & Samples

  • Develop and implement Global Medical Plans in focus disease areas at the country level
  • Facilitate 1:1 and group scientific interactions with healthcare professionals
  • Serve as Shire presence at external meetings including scientific symposia and cooperative group meetings
  • Collaborate appropriately with KOLs and Investigators to identify areas of shared scientific interest and advance partnerships per the guidance of the Country Medical Director
  • Coach and mentor the MSL team, in coordination with the Country Medical Director and Shared Medical Services, ensure MSLs are trained and certified as required in terms of disease area, skills, and compliance expertise
  • Under guidance of Country Medical Director and per GMA standards, evaluate MSL performance and provide constructive feedback
  • Experience in medical affairs is preferred
18

Country Medical Lead-rd Resume Examples & Samples

  • Develop and execute a medical plan for the respective therapeutic area
  • Manage Medical Affairs related to a disease/product or group of products, in the area of Brazil
  • In conjunction with the Country Medical Head, mdevelop the Brazilian medical strategy, then establish and maintain professional, peer-type relationships with key opinion leaders (KOLs) and other key clients in each of the therapeutic Areas
  • Provide professional leadership for the medical/scientific aspects of Shire HGT Brazil’s symposia, workshops, satellite symposia and other meetings, including speaker contacts, and post-conference publications
  • Coordinate, at affiliate level, medical advice and support for the company’s observational databases (e.g. Fabry & Hunter Outcome Surveys), including interactions with national physician governing boards and database related activities
  • Where appropriate, contribute to the design of Shire HGT sponsored Phase IIIb and Phase IV clinical trials consistent with publication plans
  • Contribute to the wider Regional and Global Medical Affairs group ensuring knowledge sharing and optimization
  • Assist with the training of internal personnel on Medical and scientific aspects of the business
  • Provide medical input into Affiliate and, if relevant, regional or global Business Development activities
  • Integrate discussion group for external support requests (e.g. IIRs, grants)
19

Associate Medical Lead Resume Examples & Samples

  • Gain valuable insights to understand knowledge gaps, scientific data gaps and clinical care gaps in the relevant therapeutic area to contribute to medical affairs strategy development
  • Scientific preparation of medical activities in relevant therapeutic area (including medical education, advisory board meetings etc.)
  • Develop and maintain strong network and engage with key opinion leader through scientific interactions and proactive scientific communication
  • Responsible for responding to medical/scientific enquiry in assigned therapeutic area
20

Country Medical Lead-turkey Resume Examples & Samples

  • Supporting development and implementation of Country Medical Brand Plans in focus disease areas
  • Develop and maintain “peer-to-peer” scientific relationships with key thought leaders in healthcare, academia and government organizations per KOL plans and as requested by KOLs, including the management of strategic scientific partnerships and scientific exchange
  • Collaborate appropriately with KOLs and Investigators to identify areas of shared scientific interest and advance partnerships per the guidance of the Country Medical Head
  • Serve as a bridge between as a bridge between HCPs and Shire medical, clinical and external partners
  • Respond effectively to requests for scientific exchange
  • Maintaining personal and medical team expertise in relevant disease areas and Medical Affairs and Medical Research best practices
  • In coordination with Country Medical Head and Global Medical Training, train medical science liaison team on fundament disease area knowledge and emerging evidence
  • Attend and report on relevant regional, national and international
  • A medical degree (MD, PharmD or DDS) is essential
  • Strong experience in pharmaceutical medicine Medical Affairs is essential
21

Medical Lead-biotherapeutics Resume Examples & Samples

  • Develop and maintain in depth knowledge for assigned product(s) / relevant therapeutic area(s) through attendance / participation at key internal meetings/training sessions, relevant congresses, and seminars and by regular self-study of the national/international literature
  • Establish and maintain professional and credible relationships with key thought leaders / external experts and academic centres; this will involve participating in scientific congresses, coordinating advisory boards, round-table meetings, discussion fora etc
  • Fluency in written and oral English is highly desirable in order to facilitate communications between the affiliate medical department, Regional and International Medical Affairs and other AbbVie functional staff
  • Experience being an active contributor to cross-functional teams and/or working in matrix organizations will be an advantage. Work independently with limited guidance/oversight
  • Works broadly across functions to facilitate and support the affiliate’s medical and clinical activities as necessary
22

Sweden Field Medical Lead Resume Examples & Samples

  • Leadership and medical team
  • Leads and develops a high quality medical field team
  • Has a close relationship with team members in the field ensuring high quality coaching and leading and thereby developing team members to their full potential adding value to patients, HCP´s and Biogen
  • Plays a leadership role within Medical including highly valuable collaboration within Medical as well as between functions and with external partners
  • 2 External stakeholders
  • Establishes the scientific reputation of local Biogen affiliate; develops strong peer-to-peer scientific partnerships with thought leaders in alignment with overall Biogen strategy
  • Identifies current and future unmet medical needs, building and executing on clinical field plans to address relevant questions
  • Medical plans, activities and budget
  • Leads execution of the affiliate medical plan aligned with local, regional and global plans, partnering with the affiliate commercial teams, including Market Access, Marketing, Sales and Regulatory Affairs, and executes a coherent local business plan that addresses patient needs; identifies measurable goals to insure execution of local medical affairs field related plan
  • Support identification of need for and establishment of RWE & Quality Projects in close collaboration with medical and cross functional teams and clinics/HCP´s
  • Develops and manages field team budgets for medical activities and provides input into the affiliate budgeting and planning process
  • In direction given by Affiliate Medical Lead partners and collaborates with commercial partners to demonstrate medical value of Biogen products relevant to local external stakeholders (payers, HCPs, agencies); may include providing input to all clinical trials (pre and post-marketing), developing and executing phase IVs, registries, etc. (master real-life medicine)
  • Ensure compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical field activities
  • ≥ 5 years pharma industry experience from field focus roles
  • Managing pharma budgets
  • Excellent knowledge of the Swedish healthcare system
  • Proven leadership and coaching skills
  • Ability to understand and communicate highly scientific and medical data
  • Ability to set up and conduct medical projects
  • Proactive and with a strong drive
  • Strong collaborator and ability to create stakeholder trust at different levels, and to build long-term relationships with KOLs and physicians
  • Demonstrated excellent interpersonal skills; and an ability to Influence
  • Ability to communicate effectively: Demonstrated excellent communication skills; strong presentation skills
  • Excellent technical skills with demonstrated scientific mastery in prior therapeutic areas of focus
  • Demonstrated understanding of strategic needs of an affiliate organization
  • Innovative Applicants must be fluent in both Swedish and English
23

Director, Field Medical Lead, Melanoma Resume Examples & Samples

  • Ensure team’s ability to develop and maintain interactions with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific, unsolicited product and HEOR related questions
  • Support and evaluate the FMS’s ability to effectively present information to HCPs and ability to respond to questions, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives
  • Actively assess the medical landscape by meeting with Thought Leaders to understand their needs and expertise. Continuously update own knowledge in treatment strategies, products, unmet medical needs, clinical trials and scientific activities. Understand the competitive landscape and actively prepare to address informational needs of customers
  • Ensure FMS capability to collect and provide meaningful medical insights back to the medical and commercial organizations to be actioned in support of the strategy development
  • Provide direction to overall execution of the Field Medical plan
  • Ensures FM team activities are aligned with the US Medical Strategy Plan
  • Develop and oversee national Field Medical plan
  • Actively participate in the cross functional Medical Matrix Teams
  • Ensure adoption of cross-functional institution/account planning approach
  • Support Clinical Trial Activities
  • Oversee recommendations and insights to clinical development team on study and site feasibilities within the therapeutic area based on knowledge of the field and through direct contacts with potential investigators, as agreed with local medical management
  • Ensure appropriate support of HCPs in the ISR submission process as agreed with local medical management
  • Actively manage Regional Associate Directors within assigned disease space
  • Oversee directly and through RADs, all FMS activities are strategically aligned with Medical Plan
  • Support employee development
  • Ensures all employees understand and act within local business processes, including compliance guidelines, relevant FDA regulations and legal and ethical standards
  • Reports to Head of Field Medical
  • MD, PharmD or PhD, with experience in Oncology OR Science Graduate with relevant pharmaceutical experience
  • A minimum of 4 years working in a field-based Medical Management role
  • Broad Oncology knowledge and an understanding of scientific publications
  • Knowledge of the national healthcare and access environment
  • Knowledge of HEOR core concepts
  • Leading a field-based team
  • Ability to work independently and act as a team player
  • Translating scientific or clinical data into an understandable and valuable form to help physicians best serve their patients
  • Good communication and presentation skills to present scientific and/or clinical data to research or healthcare professionals
  • Developing peer-to-peer relationships with TLs, scientists and other healthcare professionals
  • 1602934
24

Myeloma Medical Lead Resume Examples & Samples

  • Developing a medical plan that is both product specific and disease area focused and in alignment with US Commercial (USC) and Headquarter Medical (HQM), translating appropriate USC and HQM strategies into effective US Medical launch and life cycle management activities
  • Leadership of USM cross-functional medical teams that include USM data generation and knowledge transfer resources to drive timely and flawless execution
  • Transparent communication and close collaboration with US Commercial & Access organizations to integrate medical perspectives into the commercialization process and ensure appropriate alignment between commercial and medical
  • Contributes when appropriate to shaping the competitive strategies around pricing and reimbursement by influencing a US perspective for the target product profile, label language and value considerations
  • Continually measure and assess the effectiveness of USM medical plans
  • Advanced scientific degree (MD, PhD, PharmD)
  • Therapeutic area scientific & clinical expertise
  • Must be familiar with all phases of oncology drug development, including clinical development, regulatory and life cycle management
  • Healthcare landscape knowledge & insight
  • Proven impact and influence with high impact national TA leaders *
  • Launch expertise *
  • Vision and strategic thinking *
  • Partnering and collaboration
  • Influencing and persuasion- negotiation skills
  • Verbal & written communication skills
  • Change leadership
  • Ability to lead and manage a complex (e.g., cross-functional, matrix designed) project team
  • Ability to build & lead diverse and results- oriented high performance teams *
  • Must have for Launch products
  • 1601917
25

Medical Lead for Weekly Injectable Team Resume Examples & Samples

  • A minimum of 5 years of experience in the Pharmaceutical business
  • Understanding of clinical needs in diabetes
  • Knowledge of the KOL's in Diabetes
26

Medical Lead, / O-lung Cancer Resume Examples & Samples

  • Lead the Lung Medical Matrix Team including Home Office Medical, Medical Information, Health Economics and Outcomes Research, Medical Education, and Launch Team
  • Oversee the development and execution of the Lung Medical Plan aligned to product strategy across the Medical Matrix including US data generation plan, communication and publication plan, advisory boards, etc
  • Active leadership and participation as core member in HQ medical teams and commercial teams
  • Build and manage relationships with key external stakeholders such as Opinion Leaders and Strategic partners
  • Other areas of oversight include competitive strategies, strategic direction for training programs, and faculty speaker training
  • MD/PharmD/ PhD/NP with knowledge of oncology (especially lung cancer) strongly preferred
  • Industry experience preferred, but not required
  • Demonstrated track record of leading a complex (e.g. cross-functional, matrix designed) project team
  • 1603952
27

Product Medical Lead-vyvanse Resume Examples & Samples

  • As directed by the Franchise Medical Lead ADHD, develop, conduct, or participate in therapeutic training programs for Shire internal departments
  • Ability to represent company’s interest in scientific forums as needed
  • Management of discrete medical projects
28

Product Medical Lead-xiidra Resume Examples & Samples

  • Demonstrated business acumen and operational skills
  • Ability to think strategically and tactically from a medical perspective about how to medically appropriately support the growth of a brand
  • Ability to work in a Global environment, across diverse cultures
29

Franchise Medical Lead-neuroscience Resume Examples & Samples

  • Leads specific NS Global Medical Teams
  • Responsible for development and in-year implementation of medical plan in the US and when applicable, global, along with oversight and/or coordination of in-year implementation by International Medical Affairs
  • Develops and manages the medical budget for assigned areas
  • Acts as a senior company representative interacting with external scientific leaders, patient advocacy groups and/or regulatory authorities
  • Development of Medical and in-line R&D strategy for the product/disease area
  • External stakeholder management and engagement
30

Medical Lead Hematology Resume Examples & Samples

  • Pharmaceutical experience of 5-10+ years that includes leadership positions in Medical Affairs and/or R&D
  • MD Strongly Preferred (specialty training 7+) years of relevant clinical experience in Oncology. PhD possible. Ideally Academic experience in Oncology as well
  • Experience and proven ability to lead cross functional teams
  • Strong opinion leader engagement experience
  • Prefer Experience in phase 3b/4 and post approval commitment research including over-sighting patient registries and REMS programs
  • Translational medicine, population-based real world research
  • Bridging with integrated care management & Quality improvement pathways
  • Understanding of Health Outcomes Research including Patient-reported outcomes
  • Passion for patient outcomes and knowledge of patient care and treatment
  • Leadership Capabilities at a senior leader level with strong organizational skills
  • Strong leadership with proven track record of change and impact
  • Proven ability to engage and influence senior stakeholders
  • Thorough understanding of drug development and pharmaceutical market support and in-depth knowledge of the Oncology with a focus on hematology (clinical evidence and real world patient management.)
  • Versatile communication skills
  • Demonstrated coaching and mentoring experience
  • Presentation and negotiation skills
  • Team and Cross-functional working -- demonstrating commitment, influencing, challenge and support
  • Fluent in English, both verbal and written
  • Strong analytical skill set
  • Demonstrated strategic agility -- Ability to anticipate and shape future based on market, business and industry trends
31

Pvrm Medical Lead Resume Examples & Samples

  • Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds
  • Responsible for the conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information
  • Leadership of the Safety Review Teams for assigned products and development compounds, and responsible for the management of ongoing and cross functional assessment of benefit risk profiles and related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds
  • Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)
  • Works with the Therapeutic Area Head to develop the strategy and implementation of safety and benefit-risk management for assigned products
  • Responsible for key content of Risk Management documents (RMPs, REMS)
  • Provide input into and support the writing of periodic reports for assigned products; provide medical interpretation, review and approval for required reports
  • Share Drug Safety and medical expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal
  • Provide expert safety input to the clinical development program for assigned products and development compounds
  • Responsible for adequate and up to date representation of safety information in Company Core Data Sheet and Investigator Brochure, and other labeling documents
  • Ensure, in collaboration with Regulatory Affairs labeling team an accurate representation and communication of the safety profile of assigned products and development compounds
  • Responsible for responses to inquiries from regulatory authorities on safety issues
  • Provide integrated safety input into all regulatory documents where required
  • Perform thorough assessment of safety profiles for Due Diligence project
  • Provide Drug Safety input for product recall issues or Health Hazard Evaluations and Dear Healthcare Professional letters
  • Perform the medical review of all adverse event reports for seriousness, expectedness and causality
  • Assist Scientists with medical opinion on obtaining follow-up information for individual cases
  • Participate in review of scientific literature: identify case reports that meet criteria for entry into the safety database; identify relevant safety articles / references involving the active ingredients of marketed products and products in development; and create literature summary sections to be included in PSURs and other required reports
  • Ensure communication of all safety issues that may impact the benefit-risk profile of assigned products/development compounds to Senior GDS management including making presentations to the Independent Safety Review Committee
  • M.D. or D.O. and at least 5 years of experience in pharmaceutical industry within Drug safety/Pharmacovigilance with both investigational and marketed products
  • At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or Risk management
  • Knowledge and understanding of national and international PV and regulatory guidelines
  • MBA or MPH (Masters of Public Health) is a plus
  • At least 2 years of Clinical Patient Care experience preferred
  • Presenting drug safety topics for regulatory authorities or at conventions, meetings, etc.Product defense before a national or international regulatory authority a plus
  • Drug safety database knowledge preferred
  • Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
32

Country Medical Lead Resume Examples & Samples

  • Supporting local team disease area and product knowledge through scientific training
  • Maintaining personal and medical team expertise in relevant disease areas and Medical best practices
  • Collaborate with Country Medical Head and Global Medical Team to provide country input into Global Medical Brand Plans and translate Global Medical Strategy to in-year Country activity plans
  • Define key performance indicators and metrics to track progress against the activity plans
  • Systematically lead identification of the scientific exchange needs of KOLs, investigators and other stakeholders in patient care, establish strong professional relationships, and provide credible scientific expertise
  • Maintain KOL plans and timely, accurately and compliantly update medical customer relationship management system
  • Support Country Medical Head in defining and leading local medical initiatives and KOL plans
  • Coordinate response within defined timeline and quality standards to unsolicited inquires from HCPs and other stakeholders received by Global Medical Affairs and referred to GMA by other Shire functions
  • Develop appropriate responses to unique inquiries as required, such as the presentation of scientific evidence and medical education
  • Contribute to medical training of field based commercial personnel as assigned
  • Track and record training activities per established SOPs/
  • In coordination with Country Medical Head and Global Medical Training, train medical science liaison team on fundamental disease area knowledge and emerging evidence
  • A medical degree (MD, PharmD or PhD or equivalent is required)
  • Able to skillfully manage challenging conversations and handle objections
  • Able to effectively lead and participate in multidisciplinary and virtual teams
33

Country Medical Lead Resume Examples & Samples

  • Supporting development and implementation of Country Medical Brand Plans in focus disease areas in the country/ cluster
  • Track and record training activities per established SOPs
  • Minimum 5 years of experience in Medical Affairs in the pharmaceutical industry is required
  • Experience in the rare disease is preferred
34

Country Medical Lead, Oncology Resume Examples & Samples

  • 7 – 10 years experience in customer-facing roles is preferred
  • 7 - 10 years experience in medical affairs is required
  • A medical degree (MD) is preferred
  • 7-10 years proven experience in biopharmaceutical medicine in Medical Affairs or Clinical Research is required
  • Experience in the Rare disease areas, ideally Oncology
  • Able to expertly manage challenging conversations and handle objections
  • Strongly focused on customer and patient needs
  • Team and individual activity plan development overseen by Country Medical Head
  • Scientific project design and management
  • External stakeholder management and interaction
35

HQ Medical Lead, Immuno Resume Examples & Samples

  • Lead the Medical Plan Development and execution for the brand
  • Partner with Commercial colleagues to integrate Medical perspective into the commercialization process
  • Connect to the external environment to identify and translate medical insights. Role model and lead knowledge transfer to and from HQ to Markets
  • Provide Medical input/perspective at key forums
  • Broad experience in Oncology with specific expertise in the tumor(s) preferred
  • Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills
  • 1604356
36

Medical Lead Resume Examples & Samples

  • External stakeholders
  • Establishes the scientific reputation of local Biogen affiliate; develops strong peer-to-peer scientific partnerships with thought leaders in alignment with overall BIogen strategy
  • Identifies current and future unmet medical needs, building clinical plans to address relevant questions
  • Leads and develops a high quality medical team
  • Plays a leadership role within Medical including providing best-practice sharing across countries, therapeutic areas, products etc
  • Medical plans and activities
  • Leads development of the affiliate medical plan aligned with local, regional and global plans, partnering with the affiliate management team, including Market Access, Marketing, Sales and Regulatory Affairs, establishes and executes a coherent local business plan that addresses patient needs; identifies measurable goals to insure execution of local medical affairs plan
  • Develops and manages budgets for medical activities and provides input into the affiliate budgeting and planning process
  • Partnering with commercial
  • Partners and collaborates with commercial and market access to demonstrate medical value of Biogen products relevant to local external stakeholders (payers, HCPs, agencies); may include providing input to all clinical trials (pre and post-marketing), developing and executing phase IVs, registries, etc. (master real-life medicine)
  • Partnering within R&D
  • Supports regulatory strategies for registration of new products by providing local expertise
  • Governance/compliance
  • Ensure compliance with external laws and internal regulations regarding the appropriate conduct of Affiliate Medical activities
  • > 10 years of Pharma industry experience
  • Experience from leading medical affairs teams and departments
  • Good leadership, management and planning skills
  • Good understanding of marketing principles and strategies
  • Extensive knowledge of all aspects of drug development, GCP and local regulations, including regulations of Promotional materials. Familiar with global regulations
  • Preferably course in Pharmaceutical Medicine
  • Experience from Marketing Authorization Application (MAA) processes for new drug application
  • Extensive experience as study physician or investigator
  • Extensive knowledge of clinical trial design statistics and pharmacokinetics
  • Experience from involvement in reimbursement applications
  • Able to act as mentor for Biogen colleagues
  • Experience from critical media relations
  • Knowledge and understanding of local health care system / market dynamics, regulations, policies and SOPs, health economic techniques and trends
  • Demonstrated ability to build & lead a team and develop a high performing organization
  • A proven track record of successfully leading and developing teams
  • Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level
37

Senior Director Medical Lead Resume Examples & Samples

  • Accountable and responsible for design and final recommendations in clinical development plan for their therapeutic product(s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions
  • Leads the global medical team(s) to design, implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval
  • Leads AIRM medical programs when required as part of post marketing requirements
  • Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Global Development Project Leader (GDPL))
  • Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy
  • Negotiates milestones and ensures clinical development objectives are met (in conjunction with Global Project Development Leader)
  • Plans for resources required both within the Medical Sciences organization and in conjunction with the Global Development Project Lead (GDPL) and the Global Development Operations
  • Lead (GDOL) to accomplish the objectives in a timely and resource-efficient fashion. This includes the number of employees and contractors needed
  • Responsible, in collaboration with Clinical Sciences, for developing, recommending, adhering to the clinical development budget
  • Motivates global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Global Project Development Leader)
  • Responsible for keeping GDPL, other project physicians, Global TA Head informed of clinical progress and any critical medical issues and especially the emerging safety profile
  • Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Global TA Head
  • Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions
  • May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans
  • Presents to senior management and external audiences various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans
  • Incorporates Health Economics Outcomes Research requirements into protocol design
  • Collaborates with Medical Directors across TA and may have oversight of study physician contractors
  • Budget: allocated to the Global Project Team budget
  • Responsible for decisions and advice in scientific, clinical and/or technical areas that can impact development timelines/regulatory review periods/acceptance and create
  • Reports to the Global TA Head or to the Executive Medical Director TA Head
  • Matrixed relationship to colleagues on the Global Project Team, Clinical Operations, Statistics, Regulatory Affairs, Clinical Pharmacology and Medical Affairs
  • Collaborates with the APGD Global Development Project Leaders in assuring the smooth function of the Global Project Team
  • Accountable for integrating medical aspects of the project with the Asia Development colleagues and with colleagues running country specific registrational studies
  • Medical Degree (or Medically Qualified) with post graduate qualification and specialization in the appropriate specific therapeutic area/or one of the groups preferred
  • Must have at least 7 years of pharmaceutical industry experience specifically in human drug development
  • Proven record of being a successful medical leader and a study clinician
  • Experience managing drug development programs
  • Experience designing, implementing and conducting clinical studies, to produce both timely and high quality data
  • Proven ability to get results in a matrixed management environment
  • Moderate (up to 25%) travel required
38

Associate Director, Account Medical Lead Resume Examples & Samples

  • Utilize expert knowledge in population-management strategies, priorities, challenges, and evidence needs to develop medical strategies and tactics for Corporate/National accounts
  • Work closely with Director-level commercial Account Management (AM) to identify and appropriately engage Corporate/National account medical decision makers (C-Suite, VP level) to have the most accurate and current data to make the best decision for their populations
  • Lead cross-functional medical affairs team to ensure credible and transparent scientific information exchange to build stronger, trusting relationships with Corporate/National accounts
  • Lead cross-functional medical affairs team (HEOR, Med Ed, Med Info, etc) to execute partnership opportunities with Corporate/National accounts
  • Considered an expert in the understanding of the US Healthcare Environment (Healthcare Reform, Quality, Population Health priorities, the evolving HIT landscape, EHR, CER, Patient-centered research)
  • Ten (10) years of post-doctoral healthcare, pharmaceutical or managed care experience
  • Three (3) years of proven ability to develop medical strategies and execute medical tactics within large, complex, high profile accounts
  • Extensive knowledge of the US healthcare insurance market and US Corporate/National Payers, healthcare trends, and their impact on the healthcare industry
  • Senior level influence and credibility with the ability to engage senior executives
  • Ability to maintain a command of a large amount of scientific information across multiple therapeutic areas and show effective written/verbal communication skills
  • Residency and/or post-doctoral training in a pharmaceutical industry/health system/payer setting is desired
39

Country Medical Lead-france Resume Examples & Samples

  • Collaborate with Country Medical Director and Global Medical Team to provide country input into Global Medical Brand Plans and translate Global Medical Strategy to in-year Country activity plans
  • Participate in country-level KOL planning
  • Provide medical support to Shire’s clinical research programs and registries
  • Serve as a bridge between HCPs and Shire medical, clinical and external partners
  • Develop/increase personal and team knowledge of medical literature and critical appraisal of scientific publications
  • Focus on personal accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence; highly reliable and predictable for colleagues and customers
  • Mastering Dutch and English language; knowledge of French language beneficial
40

Lymphoma & Leukemia Medical Lead Resume Examples & Samples

  • Leadership of USM cross-functional medical matrix teams that include USM data generation and knowledge transfer resources to drive timely and flawless execution
  • Developing respective medical plans that are both product specific and disease area focused and in alignment with US Commercial (USC) and Headquarter Medical (HQM), translating appropriate USC and HQM strategies into effective US Medical launch and life cycle management activities
  • Active leadership and participation as core member on the Headquarter Medical Team and closely collaborating and partnering with worldwide counterparts to craft the HQM plan that ensures US market needs are addressed
  • Externally focused and connected to high impact external influencers in order to identify and translate key insights and to appropriately drive adoption of BMS medicines
  • Leadership of TA aligned field facing resources that provide them with the necessary coaching to ensure customer objectives are met
41

HQ Medical Lead, Immuno Resume Examples & Samples

  • Lead the Medical Plan development and execution for the brand for GBM and H&N
  • Participate as a core member in the Development Team to provide input into development strategy including the non-registrational data generation plan
  • Partner with the WWBT to integrate a medical perspective into the commercialization process
  • Drive ISR review through the RERR teams
  • Connect to the external environment to identify and translate medical insights. Role model and lead knowledge transfer to and from HQ to the regions/markets
  • Partner with the Publications/Content team to develop and review key content for congresses, manuscripts and FAQs
  • Provide data dissemination via data rollout plans and training
  • Build, forecast and track/adjust the Medical budget and resources
  • Broad experience in oncology with specific expertise GBM or H&N or rare tumor types
42

Regional Medical Lead Resume Examples & Samples

  • Have a university degree in medicine ( MD)
  • Proficiency in MS Office Applications
  • Planning and organization
  • Identify HCPs with specific Medical Information (MI) needs or clinical expertise to inform GSK. Develop list of appropriate HCPs to address business need
  • Initiate introductory meetings to introduce yourself, your role and start to uncover HCP needs Agree upfront the frequency of interaction with each HCP and their specific information needs and interests - deliver a tailored customer service
  • Engage in scientific dialogue aligned with Medical Plan & HCP needs
  • Pre-planned informal discussions to seek insights on disease and product
  • Standing information requests & one time responses to requests from HCPs
  • Check in visits to follow up with HCPs, uncover further needs (no more than once/qtr)
  • Act in a promotional capacity as an expert speaker to deliver on-label scientific talks at promotional group meetings (audience ≥3)
  • Report and share Medical Insights
  • Adapt individual HCP plans based on interactions
  • Alignment on plans with other functions
  • Review activity measures including HCP feedback on interactions
  • Communicate external-facing activity metrics to cross-functional groups
  • Attend scientific seminars, congresses courses and meetings within and outside the company
  • Actively contribute in medical projects and scientific engagement activities
  • Reports spontaneous and clinical trial adverse events related to GSK products
  • Helping to identify and contact potential investigators and sites for participation in GSK clinical studies. Helping in the feasibility process
  • Acting as a point of contact for investigator-initiated CRT proposals and a link with the local medical department. Liaising between investigators and the local medical department with regard to study logistics/implementation, reporting of adverse events etc
  • In coordination with sales manager & medical lead to establish training needs and perform regional trainings for the field force
  • Provide medical trainings to relevant brand team members regarding relevant GSK product(s) and therapeutic areas , using medically approved training materials
43

Global Medical Lead-lifitegrast Resume Examples & Samples

  • Serves as a key medical resource on Xiidra/DED
  • Maintains a high level of expertise on the disease area
  • Develops and maintains knowledge of US pharmaceutical regulations, guidelines, codes of practices and Shire policies related to all medical activities
  • As directed by the Head US Ophthalmic Medical to assist in developing, conducting in therapeutic training for internal stakeholders including the field-based medical team
44

Global Product Medical Lead Rare GI Resume Examples & Samples

  • Support definition of global medical strategy and plans
  • Work with the GFML and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • As delegated by the GFML, lead functional (e.g. publications, medical communications, medical training) and in-line R&D teams in developing plans supporting global medical strategy
  • As delegated by the GFML, collaborate with commercial to ensure aligned and medically appropriate commercial strategy, planning and execution
  • As delegated by the GFML, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
  • Work with GFML on in-year implementation of global medical strategy
  • As delegated by the GFML, directly implement in plans in the US and/or guide International in-year implementation of medical strategy, potentially including
  • Providing physician leadership for scientific communications, including standard responses and publications
  • Providing medical review of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
  • 2Interaction with external stakeholders in alignment with customer needs and medical strategy
  • Act as a company representative with external scientific leaders, policy makers, patient advocacy groups and/or regulatory authorities
  • 1Maintenance of knowledge base
  • Experience in gastrointestinal disease and immunology through clinical experience, biopharmaceutical experience or education is preferred
45

Medical Lead Resume Examples & Samples

  • Co-ordinate health care professional insights and ensure sharing with relevant internal stakeholders
  • Co-Lead with Marketing, the local tumour cluster oncology team and provide input in the company strategy for allocated tumour types
  • Recruit, manage and develop the local Disease Area Specialists
  • Drive development and execution of the pre-launch plans for individual tumour types and medical plans more generally
  • Manage the development and delivery of non-promotional activities through Disease Area Specialists and the field medical team aligned to company and country needs and support the commercial team with the development of promotional material
  • Coach the team to drive full compliance with local company policies and procedures
  • Be responsible for Medical strategies for all the relevant tumour types
  • A registered physician or UK registered pharmacist is strongly preferred. Exceptional candidates with a scientific background may be considered
  • Substantial Medical affairs experience in oncology (minimum 2 years including a senior DAS / Medical Advisor role) preferably in a large market
  • Clinical experience in Oncology preferred, ideally involving lung, renal, melanoma, glioblastoma, head and neck or gastrointestinal cancers
  • Significant experience in the review and approval of promotional and non-promotional materials and an excellent understanding of the ABPI Code of Practice and must be a code signatory
  • Experience in self assessment activities to drive full ongoing compliance with core processes and procedures
  • Experience in effective working in a cross-functional and matrix team-structure
  • Experience in working with/leading a local team and driving cross functional activities
  • Track record in supporting the delivery of UK HTA submissions
  • Strategic and goal-oriented thinking
  • Willingness/ability to travel
  • Experience in product launches
  • European/regional medical/project experience
  • Understanding of the principles of market access
  • Strong knowledge of oncology
  • Rich insight into the evolving UK health care environment, especially in oncology
  • Deep insight into the UK Code of Practice
  • Understanding of core Company policies and procedures
  • An opportunity to work within a leading Immuno-oncology company / team on novel products which have the ability to transform patients’ lives with cancer
  • Ability to lead and shape the UK / Ireland’s strategy for biomarker research and execution of implementation within BMS
46

Medical Lead, GI Resume Examples & Samples

  • Leads development and execution of US medical strategy for GI products, appropriately aligned with overall global strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance)
  • Serves as the US expert within Shire in support of the products and disease areas
  • Responsible for the development and in-year implementation of the medical plan in the US
  • As needed, provide medical review to promotional and non-promotional materials
  • Establish appropriate strategic partnerships with centers of excellence and KOLs in areas of scientific interest
  • Maintain a high level of expertise on the disease area
  • As directed by the Head US Medical, IM, develop, conduct, or participate in therapeutic training programs for Shire internal departments
47

Global Medical Lead Transplantation Resume Examples & Samples

  • Work with the Global Medical Affairs Franchise Lead, Transplantation, to develop and execute multi-year global medical strategy for the specified Product/Disease Area, appropriately aligned with overall strategy and incorporating R&D functional strategies (clinical, regulatory, HEOR, PV, compliance) in accordance with the Global Medical Planning Process
  • Work with the Global Medical Affairs Franchise Lead, Transplantation, on the development and in-year implementation of the medical plan in accordance with the Global Medical Planning Process. Actively participate in Late Product Team activities, to include chairing medical sub-teams (matrix teams)
  • Serve as Global Medical representative on standing and project-based cross-functional teams (LPTs, EPTs etc)
  • As needed, provide Medical review for non-promotional materials, and, eventually, commercial promotional materials following drug approval
  • As directed by the GMA Franchise Lead, Transplantation develop, conduct, or participate in therapeutic training programs for Shire internal departments
  • A medical degree is required, with sub specialization in nephrology, transplant nephrology (preferable), transplant surgery (preferable), hematology, or transplant hematology (preferable)
48

Regional Medical Lead Resume Examples & Samples

  • Ideally a minimum of 15 years of experience in pharmaceutical industry (7 years in Medical Department)
  • Capabilities to manage a medical team
  • Precise and accurate working style
  • Strong ability to communicate medical information
  • PC skills (MS office)
  • Willingness to travel on regular basis (50+%)
49

Medical Lead Haematology Resume Examples & Samples

  • Lead the development of the medical affairs team strategy for allocated therapy area
  • Regularly coach/mentor all direct reports to develop effective performance management
  • Conduct regular personal development plan
  • Provide training provision in order to meet development needs
  • Conduct recruitment interviews/assessments as required
  • Review summarised literature searches, analysed clinical papers, attend conferences, courses and other such events to be aware of the latest scientific and clinical advances
  • Monitor competitor promotional and scientific activities to understand their ongoing strategies, as well as to assess their compliance with the Code of Practice
  • Meet with identified key customers and researchers on a regular basis through meetings, conferences etc
  • Manage and maintain positive relationship with Key Opinion Leaders
  • Deliver scientific and medical content for medical advisory boards, as well as chairing/co-chairing
  • Be the point of contact for principal investigators proposing investigator initiated studies
  • Support communications team with patient advocacy groups and their initiatives
  • Represent the company to professional groups/bodies e.g. ABPI Cancer Subgroup, by
  • Attending meetings etc
  • Lead medical affairs engagement in the UK Country Value Team, feedback insights from customers
  • Engage with internal stakeholders on topics of mutual interest in order to encourage optimal use and/or understanding of Janssen products
  • Network with the Global and EMEA Medical Affairs, R&D, GCO, SKM, Medical Education and marketing teams to ensure free flow of information and ideas between the different teams, while aligning objectives
  • Complete annual Drug Safety and HCC Awareness training
  • You will be registered with Royal Society of Pharmacists or GMC or equivalent for MBBS
  • You will have extensive experience in Haematology/ Oncology
  • Extensive experience in a similar role is desired
  • You will have strong man management experience with strong examples of coaching, mentoring and leading
  • You will be strategic in your approach with the ability to consider the bigger picture
  • You will be able to build strong relations with the ability to influence, collaborate, lead and delivery on all areas of the above job description
50

Regional Field Medical Lead Resume Examples & Samples

  • Generate therapeutic, customer, and market insights – have the therapeutic expertise, understand the needs of OLs and uncover the important local scientific issues, opportunities and required actions
  • Be the scientific leader in the field to continue to train and monitor the MS scientific understanding of Gilead therapeutic products
  • Provide on-going coaching and oversight of MSs to ensure timely, accurate, and succinct communication of scientific evidence on Gilead products and related disease states
  • Establish team and individual goals and objectives (including both quantitative and qualitative measures) and implement processes to routinely monitor progress. These processes include: Account and OL coverage and planning, metrics review, MS activities prioritization, and field visits
  • Support the creation and execution of the MA POA in collaboration with MA leadership
  • Successful integration of the MS roles within each Medical Scientist’s assigned geography and accounts including appropriate coordination with the Commercial teams
  • Coordination of MS participation in Gilead advisory boards, symposia and educational programs, and conference planning
  • Excellent operational execution, driving the development, deployment and appropriate use of field-based technologies to ensure timely and accurate reporting of in-bound data requirements
  • Manage for operational excellence including goal setting, budget management, ensuring timely and accurate completion of MS timesheets, submission of expense reports, recording of OL interactions, and required training
  • Frequent travel required, occasionally with short notice
  • Exhibit Gilead’s core values: integrity, teamwork, accountability, excellence, and inclusion
51

Dshs Specialized Medical Lead Resume Examples & Samples

  • Assigns work to financial staff
  • Audits/Reviews financial work of staff including spenddown case audits and finalization of spenddown cases
  • Conducts training for financial staff
  • Act as a job coach for financial staff
  • Maintains and reviews procedures for efficient workflow
  • Performs more complex duties in relation to establishing eligibility, rule interpretation, planning and procedural development
  • Verify and establish overpayments and completes referral to the Office of Financial Recovery
  • Have a basic understanding of the administrative hearing process, review cases to help decide if a hearing request can be settled prior to submission and assure appropriate action is taken
  • Assist customers with the process of applying for Apple Healthcare by entering information into the Health Plan Finder (HPF) system on behalf of the clients
  • Conduct interviews and responds to individuals reporting changes, requesting information or needing referrals to other programs/agencies and take appropriate case actions
  • Acts as unit supervisor in absence of the supervisor, including attendance at meetings, case counseling and decision making
  • Experience includes examining/processing loan applications, medical insurance or rehabilitation claims, unemployment insurance claims, or a job providing staff support in financial eligibility determination, or in a job analyzing, verifying, and evaluating financial data and information, will substitute year for year, for the required education/experience
52

Country Medical Lead-ophtamology Resume Examples & Samples

  • Define specific medical programs and activities (e.g. medical meetings, disease state education, advisory boards) and associated resource requirements and budgets
  • Develop and update knowledge of applicable pharmaceutical guidelines and regulations, including ICH, GCP, Rx&D Code of Ethical Practices and company policies
  • Attend and report on relevant regional, national and international scientific and patient advocacy meetings as assigned
  • Experience in customer-facing roles is preferred
  • Establishes highly credible relationships and has personal impact through engaging respectfully and professionally
53

Country Medical Lead Resume Examples & Samples

  • Medical education (Medical Doctor)
  • > 6 years of clinical research, medical affairs and access experience, 4 years of which should be from a pharmaceutical or biotechnology company
  • 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
  • Therapeutic area knowledge
  • Network of customer contacts in therapeutic area
  • Knowledge of local pharmaceutical industry and legal/health system environment
  • Finance/budgeting and resource management experience
  • Track record of leadership
54

Product Medical Lead, Hemophilia A Resume Examples & Samples

  • Advanced scientific degree (MD, PhD or PharmD)
  • Experience or training in Hematology and bleeding disorders
  • Experience in medical affairs function
  • Good understanding of critical processes in R&D in pharmaceutical environment (eg. drug development and approval, clinical trials and investigator-initiated trial processes)
  • Experience in creating post-approval studies and medical strategies and launch plans
  • In-depth and up-to-date knowledge of Shire products and competitors’ products
  • Min. 5 years previous pharmaceutical work experience in Medical Affairs or Clinical Development/R&D
55

Area Medical Lead-latam Resume Examples & Samples

  • Medical Degree, high preferable rheumatologist, internal medicine or immunologist
  • Broad drug development expertise with robust knowledge of regulatory/ market access and reimbursement requirements
  • Significant experience in Medical Affairs in the relevant therapeutic area, including launch/ pre-launch support requirements and life cycle management
  • Robust understanding of internal and external promotional codes of practice and regulations
  • Demonstrated ability to assess evidence generation needs; review and develop Phase IIIb/IV protocols; and review ISSs for scientific merit
  • Preferable broad clinical experience in rheumatology or immunology with clinical experience or training on lupus treatment
  • Demonstrated ability to manage complexity and cultural diversity and previous cross-portfolio and above-country experience preferred
  • Cross-portfolio accountability for both insight generation and execution of global strategies in relevant LOCs
  • Excellent communication skills (current or previous medical academic role)
  • Fluency in English and Spanish
  • YOU need to build high performing medical networks across the assigned Latam countries in collaboration with the Area Medical Director
  • Recruit and develops high caliber individuals for medical teams the therapeutic area (where applicable)
  • Engage with senior stakeholders to facilitate world class launches and life cycle management, including reviewing and optimising medical affairs tactical plans and sharing learning/ best practice
  • Ensure medical colleagues in assigned countries have a robust knowledge of clinical and market access evidence for new products, supporting their preparation for launch – using Global/Area-approved materials
  • YOU will resolve issues and removes barriers to successful implementation of global medical affairs strategies and tactical plans in Latam
  • Drive excellence in external engagement with key stakeholders (HCP’s, Patients, Payors and Regulators) and build strong external networks
  • Coordinate the generation of medical insights across Latam and integrates/ prioritise these to inform global medical affairs/ evidence generation plans where appropriate (by exception)
  • Ensure visibility of LATAM Experts and act as a conduit between home and host markets sharing experts across LATAM within therapeutic area under AML responsibility
  • Communicate to external audience the scientific information of our portfolio,speaking on behalf of GSK
56

HQ Medical Lead, Immuno Resume Examples & Samples

  • Lead the GBM Medical Plan Development and execution for the brand
  • Broad experience in Oncology with specific expertise in GBM preferred
  • Experience in designing and leading clinical trials
57

Global HQ Medical Lead-o-gi Indications Resume Examples & Samples

  • Partner with Full Development Team to input into development strategy including non-registrational data plan
  • Provide medical review of brand content to align with overall strategy
  • Advanced scientific degree (MD, PhD, PharmD). 5-10 years of clinical or industry experience in Oncology
  • Relevant industry experience in Medical Affairs or Clinical Development. Experience in a customer-facing role with thought leaders and key customers preferred
  • Experience leading a cross functional team including market-based medical colleagues and clinical, marketing, access and health outcomes
58

Digital Medical Lead Resume Examples & Samples

  • Major in life sciences is a must, preferably a Medical Doctor who is passionate about digital and multichannel ways of working (pharmaceutical industry experience is not a must)
  • Must have innovative personality
  • Must consistently demonstrate a high level of indirect influencing
  • Must be operationally sound, have good attention to detail and able to drive projects to conclusion with a high degree of autonomy
  • Must have a strong cross functional awareness, good negotiation skills and be able to clearly articulate and ‘sell’ the benefits of a new process/project in order to secure the necessary buy in
  • Requires patience and flexibility of approach at various stages of the implementation of a new process
  • Robust knowledge of external environment and competitor pipelines/ portfolios and ability to use knowledge to weigh up challenges and risks to GSK; devises strategies to augment and complement the GSK future portfolio
  • Understand &identify the need of the medical team members to improve the systems and competency tools
  • Details
  • Build long-term partnerships with medical publishers and scientific societies in order to bring in differentiated, high-quality content
  • Design content product workflows on regional and local levels, for wide variety of specialties through working closely with legal/compliance/governance teams as well as external editorial boards
  • Partner with e-marketing team and IT to ensure alignment with other digital projects and company’s digital capabilities
  • Conceptualize and implement email channel strategy to drive retention to the core platform
  • Strategically select content through creating content “journeys” for multiple customer segments, keeping pulse on key metrics and ensuring that content decisions are data-driven and customer-focused
  • Closely collaborate with designers and developers to ensure personalized, high-quality, timely content delivery, reflected in month-over-month growth of users
  • Design a set of key performance indicators (KPIs) and a dashboard for all of our digital medical educations channels, on regional and local levels
  • Keep track of trends and continuously innovate medical education
  • Ensure setting up a lean governance model for content review and approval
  • Serve as evangelist for content-based strategy
  • Increased cross franchise and portfolio synergies and opportunities
  • Enables digital innovation for business priorities through provision of expertise and thought leadership on areas relevant to medical
  • Strives to avoid unnecessary duplication of digital solutions
  • Constant mapping of new technologies and digital medical advances and potential new solutions that can support the business and our “Doing what patient need next”
  • Ensure optimal relationship with medical external partners
  • Act as ambassador for Medical Affairs in external congresses and meetings
59

Regional Medical Lead, Neuroscience Resume Examples & Samples

  • Develops customer-centric medical strategies for relevant products in Medical Unit portfolio under the guidance of the National Director for the Medical Unit and in collaboration with key internal partners
  • Drives execution of Medical Unit strategies by
  • Doctorate degree (MD, PharmD, Ph.D)
  • Previous experience in a MSL Field Medical based position is also preferred
  • Thorough knowledge of clinical medicine, the managed markets, pharmacoeconomics, disease management, and medical research
  • Excellent interpersonal communication and presentation skills, (including ability to network), strong personal integrity, teamwork abilities and a customer focus are necessary
  • Must possess a thorough understanding of the FDA, OIG, HIPAA, and GCP/ICH guidelines relevant to the pharmaceutical industry
  • Must be able to organize, prioritize, and work effectively in a constantly changing environment
  • Working knowledge of Microsoft Office Suite (Word, PowerPoint, and Excel) and associated hardware is required
  • Demonstrated knowledge of GCP practices and standards
  • Demonstrated technical expertise in at least one disease or therapeutic area (cardio preferred)
  • Must be a strong team player and effectively interface with other internal departments, including Corporate Customers, Regional Business Units, Marketing, Sales, New Product Commercialization, Medical Affairs, Research, and Business Analysis
  • A valid US Driver’s License and a good driving record are required
60

Global Medical Lead Resume Examples & Samples

  • Work with GMTL on defining and implementing GMA strategy and prelaunch plans
  • Work with the GMTL and Global Medical Team (GMT) to develop medical prelaunch and early access strategy, including e.g. publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area, aligned with overall product strategy
  • Supporting design and execution of clinical studies (phase IV, disease registries, epidemiological studies, outcomes surveys, etc.) in close collaboration with Therapeutic Area Clinical Development head and Global clinical Operations
  • Serving as Global Medical representative on standing and project-based cross-functional teams
  • Experience working in cross-functional teams at the brand or disease area levels in country, regional or global organizations is preferred
61

Medical Lead, Oncology Resume Examples & Samples

  • Board certification in Oncology or related field is preferred
  • A minimum of three years of clinical or managerial experience in the biopharmaceutical industry or equivalent experience is required
  • Experience in pharmaceutical trial design and conduct (Phases II-IV) within the pharmaceutical industry, CRO or academia is preferred
  • Excellent written, oral and presentation skills are required
  • Strong organizational skills are a must
  • A demonstrated ability to work in a matrix type environment with interaction with cross-functional teams is preferred
  • This position requires up to 25% annual travel (domestic and international).9733160701
62

Country Medical Lead Ophthalmology UK Resume Examples & Samples

  • Support the GMTL with development and implementation of Global Medical Plans in focus disease areas at a country level
  • Within designated disease areas, systematically lead identification of the scientific exchange needs of Key Opinion Leaders, investigators and other stakeholders in patient care, establish strong professional relationships and provide credible scientific expertise
  • Maintain personal and medical team expertise in relevant disease areas and Medical best practices
  • 15% of time:Develop and implement Global Medical Plans in focus disease areas at the country level
  • Collaborate with Country Medical Director and Global Medical Team to provide country input into Global Medical Plans and translate Global Medical Strategy to in-year Country activity plans
  • 25% of time: Systematically lead identification of the scientific exchange needs of KOLs, investigators and other stakeholders in patient care, establish strong professional relationships, and provide credible scientific expertise
  • 25% of time: Leading the design and implementation of best-in-class scientific programs with external KOLs, investigators and Global Medical Affairs and Global Clinical partners
  • Support Country Medical Director in defining and leading local medical initiatives and KOL plans
  • 20% of time: Manage the disease area Medical Science Liaison team
  • Lead definition of and monitor execution against field medical activity plans aligned with the in-year medical plan
  • 5% of time: Oversee and participate in responding effectively to requests for scientific exchange
  • 5% of time:Support local team disease area and product knowledge through scientific training
  • 10% of time:Maintain personal and medical team expertise in relevant disease areas and Medical Affairs and Medical Research best practices
  • Maintain knowledge base and scientific expertise on all assigned Shire disease areas and products
  • MBBS or BSc. In Pharmacy with PhD in science or specialty,
  • ABPI certified final signatory,
  • Significant experience in biopharmaceutical medicine in Medical Affairs or Clinical Research is required,
  • Experience designing and leading clinical or research studies is preferred,
  • Experience in customer-facing roles is preferred,
  • Experience in Ophtalmology
63

Franchise Medical Lead Immunology Transplant Resume Examples & Samples

  • A medical degree is required. Post graduate training in transplantation (Surgeon or Physician) and clinical experience in transplantation (SOT, HSCT) is extremely desirable
  • Ability to think strategically from a medical perspective about how to medically appropriately support the growth of a brand
  • Strong clinical skills and understanding of clinical trial design
  • Unquestioned ethics are a must
64

Global Medical Lead Fabry / Gaucher Resume Examples & Samples

  • A medical degree is required (only for MD role)
  • A scientific degree (ie PhD, PharmD) is required (for non MD role)
  • >5 years (for Director) or > 2 years (for Ass. Director) of experience in biopharmaceutical medicine, preferably within a matrix or franchise structure
  • Experience in (pre)launch activities is required (for Director role)
  • Ability to think strategically and tactically from a medical perspective about how to medically appropriately support the launch and growth of a brand
  • Ability to manage teams and drive initiatives without direct line management authority
65

Country Medical Lead Hematology Resume Examples & Samples

  • A medical degree (MD) is strongly preferred; an advanced degree in life sciences is required
  • Experience designing and leading clinical or research studies is preferred
  • Able to expertly exchange scientific ideas and information openly and effectively with key opinion leaders and with colleagues
  • Strong ability to partner and collaborate appropriately with Commercial functions
  • Complexity and Problem Solving
  • Team and individual activity plan development overseen by Country Medical Director
66

Country Medical Lead Resume Examples & Samples

  • Support the Country Medical Director with development and implementation of Global Medical Plans in focus disease areas at a country level
  • Oversee and support the Immunology Homecare Service through direct report
  • Lead the design and implementation of best-in-class scientific programs with external KOLs, investigators and Global Medical Affairs and Global Clinical partners
  • Lead specific projects per the Global Medical Plan
  • 20% of time
  • 25% of time
  • Manage the Immunology Homecare Nursing team and Homecare Coordinator
  • Lead definition of and monitor execution against homecare nursing activity plans aligned with the in-year medical plan
  • Work with Country Medical Director to secure required tools and resources for Homecare Nurse effectiveness
  • Under guidance of Country Medical Director support the Homecare Team through direct report
  • Under guidance of Country Medical Director and per GMA standards, evaluate MSL and Homecare manager performance and provide constructive feedback
  • 10% of time
  • In coordination with Country Medical Director and Global Medical Training, train medical science liaison team on fundament disease area knowledge and emerging evidence
  • Strong focus on personal accountability and ownership – constantly challenging oneself to take responsibility for continuous performance improvement and operational excellence; highly reliable and predictable for colleagues and customers
  • Good people management skills with demonstrated ability to set goals and objectives, and establish and recalibrate priorities
67

Medical Lead-country / Country Cluster Resume Examples & Samples

  • A medical degree / relevant life sciences is required
  • Experience in biopharmaceutical medicine in Medical Affairs or Clinical Research is required
  • Key Skills, Abilities, and Competencies
  • Ability to partner and collaborate appropriately with Commercial functions
68

Biomarkers & Diagnostics Medical Lead Resume Examples & Samples

  • Works closely with US Medical Leads and medical matrix partners to deliver a US Biomarker and Diagnostic strategy and functional plan for current immuno-oncology products
  • Provide US Medical leadership to drive execution of the biomarker and diagnostic plans
  • Establishes and maintains ongoing long-term relationships with key oncology stakeholders (pathologists, oncologists, scientists) and leads thought leader activities including advisory boards
  • Develop relationships and partnerships with relevant professional organizations in the diagnostic field to inform and execute local strategies and plans
  • Partners with the World Wide Medical Teams (WWMT), US Commercial, and R&D to provide local pathology and diagnostic landscape insights into the development of their strategic plans for current and future oncology and immuno-oncology products
  • Serves as liaison for Medical and Scientific Affairs activities with diagnostic partners
  • Builds programs for biomarkers and diagnostics internal and external medical education as well as other tools for communication
  • Identify data gaps for either global or local plans
  • Maintains working knowledge of the US landscape, including competitors’ plans with ability to integrate into the overall Medical plan
  • Advanced degree (PhD, MD, or MS) with 8+ years of experience, preferably in a biomarker/translational research or diagnostic/technology context
  • Therapeutic area (Oncology) scientific & clinical knowledge
  • Understanding of the US Medical Testing environment (e.g. FDA, CAP, CLIA Guidelines) and of technology and IVD regulatory requirements for approval of a diagnostic both from the device and therapeutic perspective
  • Understanding of the operational considerations in executing biomarker and companion diagnostic strategies in clinical development
  • Experience working with thought leaders (pathologists preferred)
  • Strong analytical skills, with an ability to evaluate literature and the ability to extrapolate to medical, marketing or sales programs
  • Ability to work effectively with cross functional teams, including clinical, marketing, sales, medical affairs
  • Ability to function with excellent judgment, high integrity and in compliance with all laws, regulations and policies
69

Medical Lead Resume Examples & Samples

  • Design, lead and implement local medical strategy
  • Lead, manage and develop head office and field based medical affairs team members by providing coaching, training, regular feedback and opportunities for development
  • Develop, lead and communication the implementation of local Medical plans
  • Develop and implement a medical governance structure and measure to ensure compliance
70

Global Medical Lead Hematology Resume Examples & Samples

  • Develop and maintain knowledge of US and International pharmaceutical regulations, guidelines codes of practices and Shire policies related to all medical activities
  • As directed by the GMTL and Product Leads, develop, conduct, or participate in therapeutic training programs for Shire internal department
  • Experience in medical affairs particularly Hematology is preferred
  • Experience in supporting brands or disease area levels in country, regional or global organizations is preferred
  • Ability to work in a Global mindset environment, across diverse cultures
71

Biomarkers & Diagnostic Medical Lead Resume Examples & Samples

  • Develop and coordinate the overarching Biomarker and CDx strategy across projects in Oncology
  • Lead the development and implementation of biomarker and diagnostic strategies for individual projects and/or therapeutic areas
  • Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
  • May act as medical/scientific leader for projects within an area or across several areas
  • Support drafting regulatory documents for biomarker and CDx to enable prospective analysis in phase 1 and phase 2 studies, including investigational use of candidate companion diagnostic (pre-IVD) assays
72

Account Medical Lead, Associate Director Resume Examples & Samples

  • Working closely with commercial Account Management (AM) teams, develop medical strategies and tactics for key accounts by understanding population-management strategies, priorities, challenges, and evidence needs
  • Develop and lead initiatives from a medical engagement perspective with key accounts in order to facilitate well informed access decisions for their covered populations. Cultivate strong relationships with key medical decision makers (Pharmacy Directors, Medical Directors, VP, C-Suite) at key accounts
  • Identify partnership opportunities that pairs key external stakeholder needs with available Takeda medical resources (HEOR, Med Ed, Med Info, etc)
  • Engage payer KOLs within key accounts, when appropriate, in discussions related to collaborative research. Develop and submit concept(s) for review and approval, and may include participation on the study team, including potential authorship based on established Takeda policies
  • Lead effectively Field Medical Matrix partners (MSLs) and internal Medical Affairs experts to meet need of key accounts for specialized or deep therapeutic area, product, or other scientific expertise
  • Maintain superior product, disease state, and payer/provider environment and reimbursement expertise as required by scope of TA responsibility
  • The qualified candidate will have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D
  • Seven (7) years of post-doctoral healthcare, pharmaceutical or managed care experience
  • One (1) year of proven ability to lead cross-functional team to deliver scientific information to payers
  • Excellent communication, organizational and leadership skills
  • Excellent interpersonal and communication skills with strong competence in presenting