Exec Director, Global Regulatory Strategy Head of Inflammation

Gilead Sciences•Foster City, CA

About The Position

This role is for an Executive Director, Global Regulatory Strategy Head of Inflammation at Gilead, a biopharmaceutical company dedicated to creating a healthier world by addressing diseases such as HIV, viral hepatitis, COVID-19, and cancer. The company emphasizes collaboration, determination, and a relentless drive for scientific innovation. The position involves providing leadership to the global inflammation regulatory organization, advancing Gilead’s portfolio across the full product lifecycle (Phase I through Phase IV) in alignment with corporate objectives. The successful candidate will leverage in-depth regulatory knowledge and inflammation expertise to deliver strategic and technical guidance, including innovative and precedent-informed regulatory approaches for global registration. Key responsibilities include dissecting complex regulatory issues, providing clear strategic direction, supporting interactions with health authorities, and preparing high-quality regulatory content. The role also encompasses hiring, developing, and retaining diverse talent, fostering a culture of excellence, managing departmental budget and resources, and strengthening partnerships across Development, PDM, and Commercial functions. The Executive Director will represent Global Regulatory Affairs (GRA) at Development Review Committees (DRCs), provide regulatory oversight for due diligences related to in-licensing, external collaborations, and acquisitions, and contribute to the overall regulatory vision as a member of the Global Regulatory Affairs Leadership Team. Ensuring full compliance with applicable laws, regulations, ICH guidelines, regional requirements, and internal policies is crucial, along with maintaining awareness of the external regulatory landscape and championing high-impact initiatives.

Requirements

Advanced science degree (PhD, PharmD, MD, or MSc) with 14+ years, or Science Degree (BSc) with 16+ years of experience and regulatory leadership experience, including leadership of global teams.
Deep expertise in the inflammation therapeutic area, ideally gained through regulatory leadership of multiple global development programs and lifecycle management activities, including NDA/MAA submissions.
Proven ability to represent the company in complex negotiations with regulatory authorities in the US, EU, Japan, China, and other regions.
Strong influence, interpersonal and communication skills, with the ability to collaborate effectively across functions.
Extensive knowledge of global regulatory requirements, including ICH and regional frameworks, and the ability to assess their impact on business strategy.
Demonstrated capability to lead transformational initiatives in response to evolving legislation and regulatory expectations.
Ability to critically review complex scientific and technical documents and influence decision‑making across matrixed organizations.
Strong executive presence with the ability to navigate senior‑level stakeholder environments effectively.
Recognized internally and externally as an expert regulatory resource.

Responsibilities

Provide leadership to the global inflammation regulatory organization to advance Gilead’s portfolio across the full product lifecycle, from Phase I through Phase IV, in alignment with corporate objectives.
Leverage in-depth regulatory knowledge and inflammation expertise to deliver strategic and technical guidance, including innovative and precedent‑informed regulatory approaches to global registration.
Dissect and distill complex regulatory issues to provide clear strategic direction and support interactions with health authorities, including preparation of high‑quality regulatory content.
Hire, develop, and retain diverse top talent; set clear and aspirational goals; and coach direct reports on performance, development, and career progression.
Foster a culture of excellence and innovation, empowering teams to perform at their highest potential.
Own and manage departmental budget and resource planning.
Build, maintain, and strengthen partnerships across Development, PDM, and Commercial functions to support near‑term regulatory execution and long‑term strategic vision.
Represent GRA at Development Review Committees (DRCs) and provide impactful regulatory leadership to support robust development plans.
Provide regulatory oversight and guidance for due diligences related to in‑licensing, external collaborations, and acquisitions.
Contribute as a member of the Global Regulatory Affairs Leadership Team to regulatory vision, roadmaps, initiatives, and outcomes.
Ensure all activities are conducted in full compliance with applicable laws, regulations, ICH guidelines, regional requirements, and internal policies and SOPs.
Maintain strong awareness of the external regulatory landscape and evolving requirements impacting Gilead’s portfolio.
Develop and champion high‑impact initiatives that advance the regulatory function and enterprise goals.