Exec Director, Regulatory Affairs
Gilead Sciences
August 20, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Position Overview:
The Executive Director, Head of Precision Medicine Regulatory defines and leads enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across Gilead therapeutic areas. Ensures integration from early discovery through global registration/commercialization and is directly accountable for CDx/IVD regulatory strategy and execution.
Example Responsibilities:
- Lead development and execution of globally aligned precision medicine regulatory strategies with cross-functional stakeholders.
- Serve as regulatory SME for CDx/IVD development/validation and present to senior leadership.
- Maintain and apply knowledge of global IVD/CDx regulations; translate regulatory changes into actionable strategies.
- Provide IVD regulatory input during clinical development to ensure diagnostic compliance (e.g., FDA, EU IVDR).
- Lead HA briefing books and pre-submission meeting planning; provide inputs on key development and submission documents (e.g., IDE/IND/CTA, SRDs, PMAs, labeling).
- Lead team talent, set enterprise frameworks/standards/best practices for biomarker/CDx/IVD lifecycle management.
- Identify regulatory risks; support due diligence/business development/alliance activities; partner with diagnostic collaborators.
Requirements:
- PharmD/PhD with 14+ years’ relevant experience OR BA/BS with 16+ years’ relevant experience.
- Significant regulatory/quality/compliance experience supporting medicinal products with experience in vitro diagnostic development.
- Strong knowledge of global diagnostic regulations and molecular technologies; experience authoring/implementing processes.
- Extensive hands-on CDx/IVD regulatory strategy and submissions (global filings/co-development).
- Proven enterprise strategy + program execution; success influencing cross-functional teams in a matrix.
- Strong executive presence, analytical thinking, communication/writing, and Microsoft Office skills; travel when needed.
Compensation/Benefits (as stated): $302,005.00–$390,830.00 base salary; may include discretionary bonus, stock incentives, paid time off, and medical/dental/vision/life insurance.
Application Instructions (if applicable): Apply via the Internal Career Opportunities portal in Workday.
The Executive Director, Head of Precision Medicine Regulatory defines and leads enterprise-wide regulatory strategy for precision medicine, including companion diagnostics (CDx), in vitro diagnostics (IVD), and biomarker-driven development across Gilead therapeutic areas. Ensures integration from early discovery through global registration/commercialization and is directly accountable for CDx/IVD regulatory strategy and execution.
Example Responsibilities:
- Lead development and execution of globally aligned precision medicine regulatory strategies with cross-functional stakeholders.
- Serve as regulatory SME for CDx/IVD development/validation and present to senior leadership.
- Maintain and apply knowledge of global IVD/CDx regulations; translate regulatory changes into actionable strategies.
- Provide IVD regulatory input during clinical development to ensure diagnostic compliance (e.g., FDA, EU IVDR).
- Lead HA briefing books and pre-submission meeting planning; provide inputs on key development and submission documents (e.g., IDE/IND/CTA, SRDs, PMAs, labeling).
- Lead team talent, set enterprise frameworks/standards/best practices for biomarker/CDx/IVD lifecycle management.
- Identify regulatory risks; support due diligence/business development/alliance activities; partner with diagnostic collaborators.
Requirements:
- PharmD/PhD with 14+ years’ relevant experience OR BA/BS with 16+ years’ relevant experience.
- Significant regulatory/quality/compliance experience supporting medicinal products with experience in vitro diagnostic development.
- Strong knowledge of global diagnostic regulations and molecular technologies; experience authoring/implementing processes.
- Extensive hands-on CDx/IVD regulatory strategy and submissions (global filings/co-development).
- Proven enterprise strategy + program execution; success influencing cross-functional teams in a matrix.
- Strong executive presence, analytical thinking, communication/writing, and Microsoft Office skills; travel when needed.
Compensation/Benefits (as stated): $302,005.00–$390,830.00 base salary; may include discretionary bonus, stock incentives, paid time off, and medical/dental/vision/life insurance.
Application Instructions (if applicable): Apply via the Internal Career Opportunities portal in Workday.