Exec Director, Regulatory RWE Strategy and Innovation

Gilead Sciences · Foster City, CA

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BiometricsFull-time$325k–$420kCompany career page

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Role summary

Gilead Sciences seeks an Executive Director to lead enterprise-wide real-world evidence strategy and innovation for regulatory decision-making. This role will establish systematic approaches to RWE application across programs, work with cross-functional teams to shape regulatory strategy, and build infrastructure for credible, compliant use of RWE in health authority submissions.

What they're looking for

Advanced degree in epidemiology, biostatistics, clinical sciences, or related field
Extensive experience with regulatory real-world evidence applications and health authority engagement
Strong knowledge of FDA and EMA regulatory pathways and evolving RWE guidance
Track record leading enterprise-level strategic initiatives in pharmaceutical development
Expertise in study design, analytical methods, and real-world data validation
Demonstrated ability to partner effectively across multiple functional areas and therapeutic domains

What you'll be doing

Partner with therapeutic-area teams and regulatory affairs to identify and prioritize RWE opportunities across the development lifecycle
Develop and implement enterprise-level decision frameworks, standards and quality controls for regulatory-facing RWE
Provide scientific consultation on study design, endpoints and data validation for regulator-facing evidence packages
Prepare RWE content for regulatory submissions and represent the organization in health authority meetings and scientific advice sessions
Establish knowledge-sharing mechanisms and infrastructure to ensure consistent execution and precedent-sharing across programs

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