Exec Director, Regulatory RWE Strategy and Innovation

Job description

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 credible external partners that can extend Gilead's capabilities and impact. This durable enterprise capability will position Gilead to respond efficiently as evidentiary standards mature and to generate regulatory-grade RWE with the scientific rigor, quality and compliance expected by global health authorities. Key Responsibilities Enterprise Evidence Strategy and Partnership· Partner with therapeutic area EpiRWE Heads, Clinical Development and Global Regulatory Affairs to identify and prioritize opportunities where RWE may accelerate development, strengthen evidence packages, support label expansion, address post-marketing requirements or commitments, or improve the efficiency of evidence generation. · Provide senior scientific consultation on fit-for-purpose data, study design, endpoint and covariate ascertainment, validation, feasibility and documentation for regulator-facing evidence. · Facilitate early, cross-functional review of proposed regulatory-facing RWE approaches and provide clear, decision-ready recommendations while preserving program and functional ownership. · Translate enterprise learning and external precedents into practical decision frameworks that teams can apply across therapeutic areas and lifecycle stages. Regulatory Science and Health Authority Support· Partner with Global Regulatory Affairs, who are responsible for agency strategy and relationships, and with program and therapeutic-area teams to shape enterprise strategy for regulatory filing and engagement, as well as develop RWE and methodological content for briefing packages, meeting requests, submissions and responses to health authority questions. · Support preparation for and, when appropriate, participate in FDA Type B/C meetings, EMA scientific advice and other global health authority interactions in which RWE, external controls, hybrid designs or novel endpoints are material. · Help coordinate cross-program and cross-region RWE engagement priorities so that scientific positions are consistent, precedents are shared and agency feedback is translated into action. Study Design and Analytical Innovation· In partnership with therapeutic area EpiRWE teams, Biostatistics, and Clinical Development teams, advance fit-for-purpose RWE to support regulatory engagement, including external and hybrid controls, target trial emulation, causal inference, natural history studies, phase 0/lead-in studies, pragmatic and registry-based designs, and other innovative approaches. · Provide regulatory-science perspective on novel analytical methods, including Bayesian borrowing, complex innovative designs, estimands and the documented use of AI/ML or natural language processing in data curation, phenotyping and endpoint derivation. · Partner with clinical, patient-centered outcomes and other endpoint experts on the selection, validation and regulatory positioning of clinical outcome assessments, digital measures and other novel endpoints. Policy Shaping and External Partnerships· Monitor and translate global RWE policy and evidentiary developments into implications for Gilead programs, portfolio strategy and enterprise capabilities. · Develop and advance policy-shaping priorities related to the regulatory use of RWE, including concepts that could inform future PDUFA demonstration projects, pilots, commitments or other public-private initiatives. · Coordinate Gilead technical input to draft guidance and consultations, and represent Gilead in relevant consortia, trade associations, professional societies and multi-stakeholder initiatives in alignment with accountable internal functions. · Identify focused partnerships with academia, professional societies, trade groups, patient advocacy organizations and other stakeholders that can address gaps, test methods, build consensus or advance standards for regulatory-grade RWE. External Regulatory Centric RWE Ecosystem and Partner Strategy· Maintain a strategic view of the evolving external environment pertaining to RWE for regulatory use, including data providers, CROs, technology companies, methodological experts, academic centers and specialized service organizations. · Partner with Sourcin