Director, RWE

Director, RWE - HIV - Virology
United States - District of Columbia - Washington

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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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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Job Description

Director, RWE Virology

Position Description

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) department 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 Director, RWE Virology reports to the RWE Virology Product Lead and contributes to the development and execution of the RWE strategy in support of HIV established products. The incumbent will serve as an RWE subject matter expert within pertinent indication cross functional teams for the product(s) and a strategic partner to clinical development, medical affairs, and commercial teams by the generation of RWE at the global level.

The Director, RWE Virology HIV will design and deliver RWE required by internal stakeholders and regulators, ensuring timeliness, quality, and utility, as well as advise on methodological approaches including support of payer and provider interactions.

Success in this role requires a strong track record in the 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 manage effort and resources in a cross-functional, matrix setting.

Duties & Responsibilities
Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting established products evidence requirements for the treatment of HIV.Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment integrated evidence plans and broader strategy objectives.Generate, within time, budget, and quality standards, real-world evidence 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-authorization studies.Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.Communicate effectively the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.Contribute to the communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers.Contribute to 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 teams and initiatives.Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), as well as in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to anticipate and meet the evidence needs of regulators, payers, providers, and patients.Identify the need for, and contribute directly to, the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge.

Requirements
Doctoral degree in Epidemiology from an accredited institution. A clinical degree (PharmD, M.D, e.g.) combined with a Master's degree (M.H.S, MSc, MPH) in epidemiology from a(n) accredited institution will be considered.Demonstrable proficiency designing and conducting observational research, including protocol, statistical analysis plan, and study report development.Experience with secondary data analysis, including electronic medical record and/or medical claims databases, and with statistical analysis tools, such as SAS and R.A track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation.Six (6) years of relevant experience in the biopharmaceutical industry, preferably within cross functional teams.Direct experience with different applications of RWE, including in established product support, regulatory approvals, and/or safety commitments.Minimum of five years working in the HIV therapeutic area.Experience leading studies and projects in a matrix setting.Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.Ability to manage priorities, resources, and performance targets.Well-developed cross-cultural sensitivity.

The salary range for this position is: $201, $260, 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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