Senior Director, Epidemiology and RWE Franchise Lead (Oncology)

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Job Description

The Epidemiology and 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 Data (RWD) to help transform innovations to life-changing medicines for patients.

The Senior Director EpiRWE Oncology Franchise Lead in Early Development reports to the Executive Director EpiRWE Therapeutic Area (TA) Head-Oncology and is accountable for the development and execution of the RWE strategy in support of one or more Oncology Franchises under development. The incumbent will serve as the key EpiRWE subject matter expert within the Early Development teams (Gilead Asset Team (GAT) Early Molecule Teams (EMTs) and Development Evidence Teams (DETs)) for the relevant products within an Oncology Franchise and all its indications across the development lifecycle and serve as a strategic partner to clinical development medical and commercial teams to ensure excellence in the generation and use of RWE at the global level.

The SD EpiRWE Oncology Franchise Lead will ensure the timeliness quality and utility of EpiRWE required by internal and external stakeholders () as well as advise on methodological approaches in support of payer and provider interactions.

Success in this role requires excellence in design and conduct of epidemiologic studies/analyses direct expertise in use of EpiRWE at early stages of the product Oncology Franchise development process and the ability to lead and manage cross-functional efforts and resources.

Duties & Responsibilities

• Serve as the single point of accountability for the development execution and communication of the global EpiRWE strategy supporting early-stage clinical development evidence requirements for a specific Oncology Franchise and its pipeline/lifecycle indications in Oncology.

• Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the EpiRWE strategy in alignment with the clinical development plan and broader EMT DET and GAT objectives.

• Provide the functional perspective and subject-matter expertise especially regarding regulatory use of EpiRWE as a member of the EMTs and situational member of the DET.

• Deliver within time budget and quality standards proactive EpiRWE generation including but not limited to: natural history of disease population characterization assessment of treatment patterns and unmet need development of external comparators benchmarking of clinical outcomes and comparative safety and effectiveness research.

• Communicate effectively about the utility of EpiRWE across the product Oncology Franchise lifecycle and drive use of study/analysis results to support internal and external decisions across the Franchise.

• Ensure expert communication of observational research results including development of pertinent sections of regulatory documents publications white papers press releases etc.

• Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g. Risk Management Plan orphan or breakthrough designations Pediatric Investigation Plan query responses advisory committee briefing documents).

• Represent the EpiRWE function in internal cross-functional initiatives and external organizations such as industry associations professional societies or regulatory working groups.

• Foster close collaborations with quantitative functions within CDS (e.g. Biostatistics Bioinformatics Clinical Pharmacology) as well as in Research Clinical Research Medical Affairs and Global Value and Access to anticipate and meet the evidence needs of regulators payers providers and patients.

• Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency quality and impact of functional activities.

Requirements

• Doctoral degree (e.g. PhD MD ScD PharmD) and/or Masters degree (e.g. MSc) in Epidemiology or related discipline such as Outcomes Research Medicine Biostatistics from an accredited institution with relevant post-graduation experience; preference for that experience to be in the biopharmaceutical industry.

• A strong track record of scientific publications demonstrating expertise in observational study design analysis and interpretation and direct experience with different applications of Epidemiology and RWE especially in support of early-stage clinical development and regulatory approvals.

• Demonstrated understanding of the Oncology therapeutic area including disease knowledge current treatment practice and guidelines pertinent clinical trial endpoints and safety outcomes.

• Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.

• Ability to manage priorities resources and performance targets in a changing environment.

• Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.

• Well-developed cross-cultural sensitivity.

The role is based in UK. We are pleased to share that Gileads Stockley Park and Holborn offices are planning to come together at a new London headquarters at 1 Triton Square NW1 from approximately Q2 2027. Applicants should consider this planned location change when applying for this role. Gilead operates a flexible working policy offering a balanced approach with two days of remote working and three days working onsite.

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

Please apply via the Internal Career Opportunities portal in Workday.