Medical Affairs leader for assigned compound under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA strategy and tactical plan as part of the Global Brand Strategic Plan and leads the execution of the activities in the GMA plan including Launch Readiness and Life Cycle Management.
- Responsible for the development of the Global Medical Affairs strategy and medical objectives for the assigned compound and leads development, execution of the Global Medical Affairs plan and budget management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle management from a medical perspective
- Serves as Global Medical Affairs Team (GMAT) Lead, to gain strategic and planning alignment across the matrix team consisting of regional medical affairs and core GMA functions. Represents medical affairs function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to inform clinical development, commercialization, market access, and other cross-functional strategic discussions. Lead the team with sleeves rolled up, model the way and enable the team to act.
- Provides medical leadership to
- GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts as needed. Partners with RWE strategy and Biomarker/CDx leads on related integrated evidence generation strategies and activities as part of the GMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a Global IIS Review Committee, for assigned compound.
- Collaborates across GMA functions to develop, review, and align on key scientific communications and medical information response documents within legal and compliance regulations. Leads internal stakeholder medical education activities related to the compound data. In partnership with Medical Intelligence and Congress Planning leads, communicates and educates on related competitor data.
- Provides medical leadership in scientific engagement activities with key external stakeholders such as advisory boards, investigator interactions, congress activities, peer to peer discussions with key thought leaders. Provides medical support for scientific symposium and medical congresses within legal and compliance regulations.
- Works with Patient Advocacy leads and Grants office to incorporate the patient voice and define external medical education strategies for independent grants, respectively.
- Provides input into publication strategy, data gap analysis, and tactical planning as part of the overall GMA plan. Reviews and approves abstracts, manuscripts, and other data disclosure documents.
- Manage budgets and resources efficiently for GMA supported activities within the GMA plan, in collaboration with GMA Franchise Head
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- An advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/ scientific area is required. Experience in oncology therapeutic area is required.
- 10 or More Years Pharmaceutical industry experience or commensurate healthcare or research experience required
- 4 or More Years Minimum of 5 years of (in-house) medical affairs or related experience required, global preferred
- Must have oncology experience, specifically in solid tumors required
- Previous overall responsibility and accountability for multiple indications of one or more compounds and related GMA plan/budget for related MA activities required
- Demonstrated ability to lead and influence others internally and externally
• Experience leading matrix medical teams (e.g. GMAT) and representing medical on cross-functional leadership teams (e.g. Global Product Team, Global Brand Team, etc.)
• Relationships with key external experts
- Proven ability to manage multiple priorities at one time required
- Knowledge of ADC or other biologics, or small molecules preferred
- Demonstrated experience working with an alliance partner company preferred
Ability to travel up to 25%