Exec Director, Regulatory Affairs

Role: Executive Director, Head of Precision Medicine Regulatory, responsible for defining and leading global regulatory strategies for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across Gilead's therapeutic areas. Responsibilities: develop and implement enterprise-wide regulatory strategies, ensure compliance with global diagnostics regulations (FDA, EU IVDR, etc.), provide regulatory guidance throughout drug and diagnostic development stages, lead a team of regulatory professionals, collaborate with stakeholders, and represent Gilead in external forums. Qualifications: PharmD/PhD with 14+ years or BA/BS with 16+ years' relevant experience supporting medicinal products and diagnostics, extensive expertise in global IVD/CDx regulations, proven leadership in regulatory strategy and submissions, and experience working across multiple stages of development. HighValue: involvement in biomarker, CDx, and IVD development; support for global regulatory filings; experience with therapeutic areas supported by Gilead; deep understanding of molecular technologies and diagnostic regulations; leadership in cross-functional and external collaborations. WorkSetup: likely hybrid or on-site; travel as needed.