Exec Director, Global Regulatory Strategy Head of Inflammation

仕事内容

Key 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.

Qualifications

• 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.