Exec Director, Regulatory RWE Strategy and Innovation

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.

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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 Sourcing, Legal, Privacy, Quality and functional experts to establish fit-for-purpose evaluation criteria and support due diligence of prospective partners, including scientific credibility, data provenance and quality, regulatory experience, transparency, reproducibility, audit readiness, scalability and potential conflicts of interest.
• ·   Help functions identify credible partners for specific needs, avoid duplicative or low-value engagements, and capture performance and lessons learned to inform future partner selection and investment.
• ·   Provide scientific input to strategic vendor relationships, requests-for-proposal, capability assessments, and external investment decisions without displacing accountable business owners.
• Standards, Capability and Matrix Leadership
• ·   Co-develop and steward practical standards, templates, governance and quality expectations for regulatory-facing RWE, aligned with applicable regulations, guidance, Good Pharmacoepidemiology Practices and internal procedures.
• ·   Create forums, training and mentoring programs to strengthen regulatory and methodological judgment across RWE and partner functions and enable teams to apply consistent approaches.
• ·   Deliver concise, executive-level briefings on policy shifts, external developments, precedents, risks and portfolio opportunities.
• ·   Contribute as a member of the EpiRWE leadership team to functional vision, prioritization, ways of working and enterprise initiatives, employee development, and inform resource and investment decisions for enterprise capability, data assets and external partnerships
• Basic Qualifications
• ·   PhD, MD, PharmD, DrPH or ScD in epidemiology, biostatistics, pharmacoepidemiology, public health or a related quantitative or clinical science with 12+ years of relevant experience; OR MS/MPH in a relevant discipline with 14+ years of relevant experience.
• ·   Demonstrated leadership of observational research or RWE intended to support regulatory decision-making, including experience in at least one program in which RWE materially contributed to a submission, approval, label expansion, or post-marketing requirement or commitment.
• ·   Direct experience developing regulator-facing evidence content and participating in health authority interactions, including briefing documents and written responses.
• ·   Demonstrated understanding of late-stage clinical development and registrational evidence requirements, including applicable data standards, documentation, quality and inspection considerations relevant to observational and hybrid approaches.
• ·   Expert knowledge of the global RWE regulatory landscape and strong command of real-world data sources, fit-for-purpose assessment, feasibility, validation and advanced observational or hybrid study designs.
• ·   Ability to translate complex methodological and policy issues into clear recommendations for program teams, governance bodies and senior R&D leaders.
• ·   Proven ability to influence across a global matrix, build trusted partnerships and establish standards or capabilities adopted beyond one’s immediate team.
• ·   Experience evaluating or managing external data, research or service partners, including vendors, CROs, academic collaborators or consortia.

Preferred Qualifications

• ·   Experience working at a health authority/regulatory agency or comparable direct exposure to regulatory review and adjudication of evidence packages.
• ·   People leadership experience combined with effectiveness as an enterprise individual contributor and matrix leader.
• ·   Experience with innovative methods, such as Bayesian methods, external or historical data borrowing, complex innovative designs, estimand strategy, clinical outcome assessments, or digital and novel endpoints in a regulatory context.
• ·   Contributions to health authority policy, guidance, PDUFA-related initiatives, industry consortia, trade associations, professional societies or multi-stakeholder collaborations.
• ·   Breadth across therapeutic areas, modalities, or both more prevalent and rare disease development programs.
• ·   Strong publication and presentation record in pharmacoepidemiology, regulatory science, interventional studies or related fields; experience with AI/ML or natural language processing applied to real-world data in regulatory context is a plus.
• Additional Information
• Location: Foster City, CA. Onsite.
• Travel: Approximately 10-15%, domestic and international, including health authority meetings, partner engagements and scientific congresses.

The salary range for this position is: $324,615.00 - $420,090.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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