$302,005 – $390,830
Listed on Gilead Sciences’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
Lead regulatory strategy for precision medicine diagnostics and companion diagnostics across Gilead's drug portfolio, overseeing both enterprise policy and team execution from early development through global approval. This role suits experienced regulatory professionals with deep expertise in in vitro diagnostics, biomarker development, and health authority interactions who can influence cross-functional teams in a matrix environment.
Our summary, not Gilead Sciences’s wording. The full posting is on their site.
What they ask for
Required
- PharmD/PhD with 14+ years relevant experience OR BA/BS with 16+ years relevant experience
- Significant regulatory, quality, or compliance experience supporting medicinal products with in vitro diagnostic development
- Understanding of global policy, laws, and regulations for diagnostic development and approval
- Understanding of molecular technologies and diagnostic outcomes
- Experience supporting global regulatory strategy across multiple development stages
- Extensive hands-on experience in CDx/IVD regulatory strategy and submissions including global filings
- Advanced knowledge of regulatory requirements including IVDR and drug discovery goals
- Proven ability to lead enterprise strategy and program-level execution
- Demonstrated success influencing cross-functional teams and senior stakeholders in matrix environment
- Strong executive presence, analytical thinking, and communication skills
- In-depth knowledge of relevant health authorities and their processes
- Ability to represent Gilead to regulatory authorities in standard negotiations
- Strong project management and Microsoft Office proficiency
- Ability to lead and influence programs and projects
- Proven ability to work in team-oriented matrixed environment
Nice to have
- Experience working with one or more Gilead therapeutic areas and varying stages of drug development
- Ability to travel when needed