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 development across Gilead's therapeutic areas. Responsibilities: develop and execute regulatory strategies supporting early discovery through global registration, oversee compliance with international diagnostics regulations (FDA, EU IVDR, etc.), lead a Regulatory Precision Medicine team, provide strategic guidance for biomarker and diagnostic programs, and represent Gilead in external regulatory forums. Required qualifications: PharmD or PhD with 14+ years, or BA/BS with 16+ years experience supporting medicinal products and IVD development, deep knowledge of global regulatory policies, and extensive hands-on experience in CDx/IVD regulatory strategy and submissions. Preferred skills include experience in multiple therapeutic areas, global regulatory interactions, and leadership in matrix environments. HighValue: focus on biomarker-driven development, companion diagnostics, global regulatory compliance, and integration across discovery to commercialization. Collaboration involves cross-functional teams and external diagnostic partners. Work setup: not specified; likely global/regional scope with potential travel.