Director- Real World Evidence

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

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 Oncology reports to the Senior Director, RWE Oncology Pharmacoepidemiology and Safety Lead and contributes to the development and execution of the RWE strategy in support of an Oncology Franchise through oncology product development and commercialization. The incumbent will serve as an RWE pharmacoepidemiology and safety subject matter expert for Oncology interacting with pertinent indication sub-teams of the Global Development Team (s) (GDT) for the Franchise(s) and a strategic partner to clinical development, medical, patient safety, and commercial teams by the generation of RWE at the global level.

The Director, Real-World Evidence (RWE) Oncology Pharmacoepidemiology and Safety 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 post authorization safety studies, rapid analyses to address ad hoc epidemiologic queries /analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, including early- stage clinical development, 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 timely development, execution, and communication of specified pharmacoepidemiology and safety studies for individual products and their pipeline/lifecycle indications in Oncology.
• Provide functional perspective and subject-matter expertise on RWE methods and requirements at both the global/regional level and the TA level, including review of Pharmacovigilance and Safety analysis plans developed internally and externally.
• Ensure collaboration and coordination of Pharmacovigilance and Safety projects within RWE Oncology Product teams.
• Work within a matrix organization to deliver, within time, budget, and quality standards, post-authorization studies including, but not limited to: patient registries, studies of natural history of disease, drug utilization studies, studies of patient reported outcomes, comparative effectiveness/safety studies, and post-approval safety studies.
• Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.
• Communicate effectively about 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 delivery of 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 (e.g. PhD, MD, ScD, PharmD) and/or Master's degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with extensive experience.
• Direct experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and/or safety commitments.
• Experience 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 is preferred.
• Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
• 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.