Exec Director, Global Regulatory Strategy Head of Inflammation

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. #J-18808-Ljbffr