Exec Director, Global Regulatory Strategy Head of Inflammation
Gilead Sciences
June 27, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Key Responsibilities:
- Provide leadership to the global inflammation regulatory organization to advance Gilead’s portfolio across the full product lifecycle (Phase I–IV) in alignment with corporate objectives.
- Deliver strategic and technical guidance using in-depth regulatory knowledge and inflammation expertise, including innovative, precedent-informed global registration approaches.
- Dissect and distill complex regulatory issues to provide clear strategic direction; prepare high-quality regulatory content and support interactions with health authorities.
- Hire, develop, and retain diverse top talent; set clear goals; coach direct reports on performance, development, and career progression.
- Foster a culture of excellence and innovation.
- Own and manage departmental budget and resource planning.
- Build and strengthen partnerships across Development, PDM, and Commercial to support near-term execution and long-term vision.
- Represent GRA at Development Review Committees (DRCs).
- Provide regulatory oversight and guidance for due diligences related to in-licensing, external collaborations, and acquisitions.
- Contribute to Global Regulatory Affairs Leadership Team vision, roadmaps, initiatives, and outcomes.
- Ensure activities comply with applicable laws, regulations, ICH guidelines, regional requirements, and internal policies/SOPs.
- Maintain awareness of external regulatory landscape and evolving requirements.
- Develop and champion high-impact initiatives.
Qualifications:
- PhD/PharmD/MD/MSc with 14+ years, or BSc with 16+ years, plus regulatory leadership experience including global team leadership.
- Deep inflammation therapeutic area expertise (e.g., regulatory leadership across multiple global development programs; NDA/MAA submissions).
- Experience negotiating with regulatory authorities (US, EU, Japan, China, and other regions).
- Strong influence, interpersonal, and communication skills; cross-functional collaboration.
- Extensive knowledge of global regulatory requirements (ICH and regional frameworks) and ability to assess business impact.
- Ability to lead transformational initiatives in response to evolving legislation/regulatory expectations.
- Ability to critically review complex scientific/technical documents and influence matrixed decision-making.
- Strong executive presence with experience navigating senior-level stakeholders.
- Recognized expert regulatory resource.
- Provide leadership to the global inflammation regulatory organization to advance Gilead’s portfolio across the full product lifecycle (Phase I–IV) in alignment with corporate objectives.
- Deliver strategic and technical guidance using in-depth regulatory knowledge and inflammation expertise, including innovative, precedent-informed global registration approaches.
- Dissect and distill complex regulatory issues to provide clear strategic direction; prepare high-quality regulatory content and support interactions with health authorities.
- Hire, develop, and retain diverse top talent; set clear goals; coach direct reports on performance, development, and career progression.
- Foster a culture of excellence and innovation.
- Own and manage departmental budget and resource planning.
- Build and strengthen partnerships across Development, PDM, and Commercial to support near-term execution and long-term vision.
- Represent GRA at Development Review Committees (DRCs).
- Provide regulatory oversight and guidance for due diligences related to in-licensing, external collaborations, and acquisitions.
- Contribute to Global Regulatory Affairs Leadership Team vision, roadmaps, initiatives, and outcomes.
- Ensure activities comply with applicable laws, regulations, ICH guidelines, regional requirements, and internal policies/SOPs.
- Maintain awareness of external regulatory landscape and evolving requirements.
- Develop and champion high-impact initiatives.
Qualifications:
- PhD/PharmD/MD/MSc with 14+ years, or BSc with 16+ years, plus regulatory leadership experience including global team leadership.
- Deep inflammation therapeutic area expertise (e.g., regulatory leadership across multiple global development programs; NDA/MAA submissions).
- Experience negotiating with regulatory authorities (US, EU, Japan, China, and other regions).
- Strong influence, interpersonal, and communication skills; cross-functional collaboration.
- Extensive knowledge of global regulatory requirements (ICH and regional frameworks) and ability to assess business impact.
- Ability to lead transformational initiatives in response to evolving legislation/regulatory expectations.
- Ability to critically review complex scientific/technical documents and influence matrixed decision-making.
- Strong executive presence with experience navigating senior-level stakeholders.
- Recognized expert regulatory resource.