Senior Director, RWE Virology Safety Epidemiology Lead

Job Description

Position Description

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group within the 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 Virology Safety Epidemiology Lead reports to the Executive Director, RWE Therapeutic Area Head-Virology and has primary accountability for the execution of post authorization and other non-experimental studies, both mandatory and voluntary, in support of Virology product safety. The incumbent will serve as the key subject matter expert for Virology post marketing commitments (PMCs) and other pharmacoepidemiology activities in support of safety, and serve as a strategic partner to the RWE Virology Product Area Leads and cross-functional stakeholders to ensure excellence in the execution of all safety epidemiology activities at the global level.

The SD, RWE Virology Safety Epidemiology Lead will oversee a team of observational research scientists within a matrix organization and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of RWE Virology activities in support of safety required by internal and external stakeholders (e.g., regulators).

Success in this role requires excellence in design and conduct of epidemiologic studies, expertise in the use of data from both primary as well as secondary sources (e.g., from administrative claims, medical records, etc), expertise in the use and application of appropriate and state-of-the-art analytical methods at different stages of the product development and commercialization lifecycle, and the ability to lead and manage cross-functional efforts and resources.

Duties & Responsibilities

• Serve as the primary point of accountability for the timely development, execution, and communication of specified post-authorization/non-experimental studies for the safety of individual products and their pipeline/lifecycle indications in Virology.

• 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 PMC study protocols and analysis plans developed internally and externally.

• Ensure collaboration and coordination of Safety Epidemiology activities with RWE Virology Product Area teams

• Lead a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, safety-related studies including, but not limited to: patient registries, signal evaluation studies using secondary data, drug utilization studies, comparative safety studies, and post-approval safety studies.

• Communicate effectively about the utility of RWE and drive use of study results to support internal and external decisions.

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

• 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, Clinical Pharmacology, AI/ML Research Center), as well as partners in Clinical Development, Global Patient Safety, Regulatory Affairs, Clinical Operations, 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 Master’s degree (e.g. MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution,

• Relevant post-graduation experience within 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 RWE, especially in support of PAS.

• Preference for understanding of the Virology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.

• Strong preference for expertise in state-of-the-art methods, including AI/ML approaches, for leveraging RWD to assess safety and other questions

• Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.

• Experience leading, coaching, and managing people in a global, matrixed 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.