Senior Director, Epidemiology

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Job Description

The Real-World Evidence (RWE) 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 RWE Inflammation Product Lead reports to the Executive Director RWE Therapeutic Area (TA) Head-Inflammation and is accountable for the development and execution of the RWE strategy in support of one or more Inflammation products under development. The incumbent will serve as the key RWE subject matter expert within the Global Development Team (GDT) for the product(s) 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 Senior Director RWE Product Lead will oversee a team of observational research scientists and advocate for the appropriate level of resources to ensure the timeliness quality and utility of RWE required by internal and external stakeholders (e.g. regulators) 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 RWE at different stages of the product development and commercialization processes 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 RWE strategy supporting early-stage clinical development and post-authorization evidence requirements for a specific product and its pipeline/lifecycle indications in Inflammation.

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

• Provide the functional perspective and subject-matter expertise especially regarding regulatory use of RWE as a member of the product GDT.

• Lead a team of observational research scientists to deliver within time budget and quality standards proactive RWE 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 comparative safety and effectiveness research and post-approval safety studies.

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

• 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 RWE 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) 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 ScD) and/or Masters degree (e.g. MSc) in Epidemiology from an accredited institution with a minimum of twelve (12) years of relevant post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry. A doctoral degree in epidemiology with leadership experience and primary focus on epidemiology evidence generation especially for clinical development support regulatory submission and safety are preferred.

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

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

• Experience leading coaching and managing people in a global setting.

• 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 salary range for this position is:

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*.

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

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