Exec Director, Regulatory RWE Strategy and Innovation

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About the role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description   Job Description The Epidemiology & Real-World Evidence (EpiRWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization and aims to unlock the power of Real-World Evidence (RWE) to help transform innovations to life-changing medicines for patients. RWE is increasingly informing regulatory decisions across development and the product lifecycle. At the same time, evolving health authority expectations, modern study designs, advanced analytics and a rapidly expanding external RWE ecosystem create both opportunity and complexity for development teams. Reporting to the Vice President of Epidemiology and Real-World Evidence (EpiRWE), the Executive Director, Regulatory RWE Strategy and Innovation is a scientific and strategic leader who enables Gilead to move from ad hoc , program-specific use of regulatory-facing RWE to a more systematic and forward-looking enterprise-level approach. To advance appropriate use of RWE for regulatory decision-making, this role will provide the cross-portfolio perspective and senior expertise to interpret the shifts in the regulatory and industry landscape, identify and prioritize high-impact applications of RWE, and translate emerging policy and precedent into coherent enterprise strategy across therapeutic areas, programs and lifecycle stages. The role works through partnership with therapeutic-area EpiRWE Heads and their teams, Global Regulatory Affairs, Biostatistics, Clinical Development, Clinical Pharmacology, Patient Safety, Medical Affairs and other stakeholders. These functions retain ownership of their respective programs, studies, submissions, and relationships with stakeholders and health authorities; this role adds coordinated enterprise strategy, specialized expertise and consistent standards so that Gilead can anticipate change, apply emerging approaches deliberately and lead rather than react. The successful candidate will connect and help shape policy, methodology, external innovation and practical execution while helping build the infrastructure required to use RWE credibly and compliantly for regulatory purposes. They will establish and steward fit-for-purpose decision frameworks, templates, documentation expectations, quality controls and knowledge-sharing mechanisms that promote transparency, reproducibility, audit readiness and consistent execution across the enterprise. In doing so, the leader will help teams determine when RWE is fit for purpose, strengthen regulator-facing evidence plans, reduce duplication and variability, develop policy-shaping opportunities and identify credi

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