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Exec Director, Medical Affairs

Gilead Sciences
2023 years ago
Remote friendly (San Francisco Bay Area)
United States
Medical Affairs

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.