Oncology, Global Director Medical Affairs Melanoma
vor 4 Stunden
The Global Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans for their assigned asset(s). The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. The GDMA contributes to Life Cycle Management decisions. In addition, the GDMA leads the Medical Affairs input into the integrated data generation plans spanning outcomes research, post-registration company-sponsored studies and areas of interest for the investigator-initiated study program. The GDMA chairs the Global Medical Affairs Teams of Regional Directors Medical Affairs and other medical functions, synthesizes their medical insights from the regions and maintains an updated summary of the execution of the Medical Affairs Plans. 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 advisory boards (with Scientific Affairs) and expert input forums 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.
**Asset Management & Business Leadership**
- Consolidate actionable medical insights from all regions that help inform company decisions
- Coordinate development of Medical Goals and Strategies that address asset value proposition, insights from affiliates and regions, and clinical and value evidence gaps.
- 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, Value-Evidence, Risk Management, and Commercial Product 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
- Contributions at MISP and Sponsored Protocol Review Committees
- 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
- Develop and execute global advisory boards (with Scientific Affairs) and expert input forums 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
**Asset Regulatory Management**
- 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 value proposition requirements for most geographies
**Management**
Leads Global Medical Affairs Team (GMAT) of Medical Affairs colleagues (including Regional Directors Medical Affairs) assigned to asset(s).
**Education Minimum Requirement**:
- MD, PhD or PharmD is required (MD preferred); recognized expertise through 5+ yrs. clinical and/or research experience (incl. publications) in therapy area (clinical experience is desirable)
**Required Experience and Skills**:
- 5+ years pharmaceutical (or related) industry experience in international role with proven track record of contribution to medical, clinical or commercial strategies is required
- Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies t
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