Senior Director, Epidemiology

Overview

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, and we continue to fight against the world’s biggest health challenges. 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. We’re looking for passionate and ambitious people ready to make a direct impact. As a people leader, you are key to 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.

Role Summary

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the Clinical Development organization. It aims to unlock the power of Real-World Data (RWD) to transform innovations into 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 role serves as the key RWE subject matter expert within the Global Development Team (GDT) and acts 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.

Responsibilities

• Oversee a team of observational research scientists and advocate for appropriate resources to ensure timely, high-quality, and useful RWE for internal and external stakeholders (e.g., regulators).
• 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 aligned with the clinical development plan and broader GDT objectives.
• Provide functional perspective and subject-matter expertise, especially regarding regulatory use of RWE, as a member of the product GDT.
• Lead a team to deliver timely, budget-conscious, and quality-driven proactive RWE generation including natural history of disease, population characterization, treatment patterns, unmet need, external comparators, benchmarking of outcomes, comparative safety and effectiveness research, and post-approval safety studies.
• Communicate the utility of RWE across the product lifecycle and drive the use of study results to support internal and external decisions.
• Expertly communicate observational research results, including development of pertinent sections of regulatory documents, publications, white papers, and other communications as needed.
• Oversee 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 or regulatory working groups.
• Foster close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics) and with Research, Clinical Research, Medical Affairs, and Global Value and Access to anticipate and meet evidence needs of regulators, payers, providers, and patients.
• Identify the need for development of processes or training materials to increase efficiency, quality, and impact of functional activities.

Requirements

Compensation and Benefits

The Salary Range For This Position Is

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include medical, dental, vision, and life insurance plans. For additional benefits information, please visit the Gilead compensation, benefits and wellbeing page.

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For Current Gilead Employees And Contractors, please apply via the Internal Career Opportunities portal in Workday.

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