Exec Director, Regulatory RWE Strategy and Innovation

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.

Responsibilities

• 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

Requirements

• 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