Role Summary
Exec Director, Medical Affairs provides global leadership for post-authorization research methodology across therapeutic areas and portfolios. The role drives asset-appropriate lifecycle research strategies, oversees Medical Affairs–led research activities, and represents Medical Affairs in cross-functional governance. This position builds, leads, and develops high-performing Medical Affairs teams and collaborates with Clinical Development, Regulatory Affairs, Patient Safety, HEOR, and Commercial functions to advance strategic initiatives and collaborations.
Responsibilities
- Provide global Medical Affairs leadership for post-authorization research methodology across therapeutic areas and portfolios.
- Ensure that the respective GMA and Development TA Heads, and other members of senior management, embrace the implementation of state-of-the-art research methodologies for post-authorization (Phase 4) medical affairs research.
- Justify the rationale for proposed study methodology in cross-functional steering and/or governance committees.
- In close collaboration with the MAR Head and the MAR Therapeutic Leaders, drive the development of asset-appropriate lifecycle research strategy (e.g., market archetype context), to be implemented in the respective Integrated Evidence Plans (IEP).
- Serve as a senior Medical Affairs representative in cross-functional governance and steering committees.
- Partner with Clinical Development, Regulatory Affairs, Patient Safety, HEOR, and Commercial colleagues.
- Oversee Medical Affairs–led research activities, including protocol strategy, medical monitoring, and dissemination of results.
- Lead or oversee clinical trial protocol design and clinical study reporting for an assigned asset.
- Ensure compliance with global regulatory requirements, patient safety standards, GCP, and Gilead policies.
- Establish and maintain external scientific and thought-leader relationships.
- Consult with Development colleagues on implementing novel approaches in earlier-stage clinical trials (e.g., decentralized clinical trials).
- Provide consultation to study teams for communications, both written and oral, with health authorities, relative to study methodology or conduct.
- Represent Gilead Medical Affairs through scientific presentations and publications.
- Contribute Medical Affairs expertise to business development and strategic collaborations.
- Build, lead, and develop high-performing Medical Affairs research teams.
- May assist in the clinical evaluation of business development opportunities.
Qualifications
- MD from an accredited university is required, with extensive Global Medical Affairs leadership experience, preferably in a similar role, in either pharma or large global biotech companies.
- Clinical practice and/or biopharma industry experience in one or more of the following therapeutic areas is highly preferred: virology, oncology, inflammation and/or hepatology.
- Demonstrated experience leading high‑complexity, cross‑functional lifecycle strategies, including short‑ and long‑range strategic planning, governance, and execution.
- Prior People-management Experience, Including Direct Reports, Is Preferred.
- Proven experience engaging with and presenting to senior executives, with accountability for managing significant budgets and organizational resources.
- Established track record of delivering large‑scale, complex strategies and achieving sustained impact in dynamic environments.
- Expert‑level understanding of drug development and post‑authorization (Phase 4) research, demonstrated through leadership of lifecycle evidence strategies and plans.
- Recognized credibility in innovative study methodologies, including large simple trials, decentralized clinical trials, ambispective designs, and the application of digital technologies (e.g., patient‑generated data).
- Strong working knowledge of global pharmaceutical regulatory requirements, safety reporting obligations, and their impact on clinical research design and execution.
- Exceptional communication and organizational skills, with the ability to translate complex scientific concepts into clear strategic recommendations and executable roadmaps; demonstrated ability to influence, align, and mobilize senior leaders around cross‑functional strategies and objectives.
- Ability to travel when needed.
Skills
- Strategic leadership for lifecycle research and governance across cross-functional teams.
- Cross-functional collaboration and stakeholder management with senior executives.
- Ability to translate complex scientific concepts into actionable roadmaps and recommendations.
- Experience with innovative study methodologies (e.g., large simple trials, decentralized trials, ambispective designs, use of digital technologies).
- Strong communication, organizational, and influencing skills.
- Knowledge of global regulatory requirements and safety reporting obligations as they relate to clinical research.
Education
- MD from an accredited university.
Additional Requirements
- Travel: Ability to travel when needed.