Global Director Medical Affairs

7 days ago

Kirkland, Canada MSD Full time

Job Description

The Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline coordinates the development and implementation of the Global Medical Affairs Plans for Oncology Pipeline Assets. The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Asset Development (Sub-) Teams. In addition, the GDMA leads the Medical Affairs input into the integrated data generation plans spanning outcomes research, peri-registration company-sponsored studies and areas of interest for the investigator-initiated study program. The GDMA will interact with other TA groups (both at the global and regional level), as well with other relevant internal stakeholders - early development teams, commercial, CORE, Scientific affairs, Market Access, among others – to develop and implement medical affairs plans for the applicable assets. The GDMA builds trust with the external scientific community via peer-to-peer engagement with scientific leaders, research and educational collaborations and publications. The GDMA executes global Group Input Meetings (advisory board meetings) in partnership with Executive Directors of Scientific Affairs to remain on the leading edge of therapeutic and patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory, reputational, ethical, and other asset management issues.

This is a headquarters-based position in Our Company Research Laboratories Global Medical and Scientific Affairs (Research & Development (R&D) GMSA) but additional locations can be considered.

Primary Responsibilities:

Asset Management & Business Leadership

  • Coordinate development of medical goals and strategies that inform and demonstrate scientific & clinical value and address insights from affiliates and regions including clinical and value evidence gaps. Consolidate actionable medical insights from all regions that help inform company decisions.
  • Translate these goals and strategies into research, data analysis, scientific communication, educational, and other tactics and solutions that improve patient outcomes and enhance access, including digital solutions, patient and customer programs.
  • Contribute substantively to and be a valued co-strategist on asset cross-functional meetings: Franchise Teams, Clinical, Outcomes Research, Risk Management, and Commercial Asset Development Subteams, Publication Teams, Rapid Response Teams.
  • Inform Life Cycle Management decisions leveraging patient and healthcare country insights.
  • Support business development assessments by validating unmet medical needs, reviewing asset data (through a medical affairs lens), and recommending required medical affairs resources.
  • Support integrated data generation plans and co-develop clinical and outcomes research programs with cross-functional R&D and Observational Research colleagues that address life cycle management needs. Advise on areas of interest for the Investigator-Initiated Study Program.
  • Execute on and quickly adapt portfolio of tactics to life-cycle stage and business realities (i.e. prompt deployment of new information to the field medical staff, identify data analysis needs, and publication needs).
  • Lead medical affairs coordination in alliances that our company may have with other pharmaceutical companies.

Scientific & Technical Leadership

  • Communicates both scientific and business needs credibly and effectively across a variety of internal and external stakeholders at all levels, including external scientific leaders and key decision makers.
  • Develop/support initiatives to improve internal education about the pipeline agents and specific projects under the Innovative Strategy group.
  • Contributions at MISP and sponsored Protocol Review Committees (PRCs).
  • Builds trust with the external scientific community via peer-to-peer interactions, research and educational collaborations, interactions with global scientific societies and health organizations, publications, or other relevant stakeholders.
  • Develop and execute global Group Input Meetings (advisory board meetings) in partnership with Executive Directors of Scientific Affairs to inform life cycle management decisions.
  • Develop and execute global symposia and educational meetings. Work with Regional Directors Medical Affairs for regional symposia and meetings.
  • Participate in and contribute significantly to professional organizations, academic or regulatory working teams.
  • Successfully collaborate and lead resolution of regulatory, reputational (i.e. public relations), compliance and other asset issues management.
  • Substantive contributions to labeling committees. Ensure labels contain fair-balanced claims supported by data and supportive of asset-related medical, clinical and scientific value requirements for most geographies.

Management

  • Participate during relevant Global Medical Affairs Team (GMAT) (including Regional Directors Medical Affairs and Medical Strategy Leads) related to assigned to asset(s). Collaborate with the relevant TA teams, either at global and regional level for the execution of the relevant medical plans associated with pipeline compounds and Innovative Strategies projects.

Education Minimum Requirements:

  • MD, PhD, PharmD required; recognized expertise through 3+ yrs. clinical and/or research and/or medical affairs experience in oncology (clinical experience is desirable).

Required Experience and Skills:

  • 3+ years pharmaceutical (or related) industry experience with proven track record of contribution to medical, clinical and scientific strategies is required.
  • Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies that inform and demonstrate scientific & clinical and value evidence.
  • Experience in clinical development or outcomes research is desired.
  • Customer expertise, having a scientific leader network, and successful interactions with key stakeholders (public groups, government officials, medical professional organizations) in therapy area.
  • Proven ability to effectively communicate (written and oral) scientific and business information, both, to a variety of audiences including company management, scientific leaders and lay audiences.
  • Proven track record of translating strategies into tactics that are executed and completed.
  • Strong prioritization skills and ability to understand how decisions fit into the broader context of corporate strategy.
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