Director, RWE Virology Safety Epidemiology in Cambridge

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. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations.

As a Director in Real-World Evidence at Gilead you will:

• Work in a team of observational research scientists within a matrix organization and advocate for the appropriate level of resources and methods to ensure the timeliness, quality, and utility of RWE Virology activities in support of safety required by internal and external stakeholders (e.g., regulators).
• Report to the Senior Director, RWE Safety Therapeutic Area Lead-Virology and are responsible for the execution of RWE safety epidemiology studies across the product lifecycle, including pediatrics, post authorization studies (PAS), and other non-experimental studies, both mandatory and voluntary, in support of Virology products.
• 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 partner to the RWE Virology Product teams and cross-functional stakeholders to ensure excellence in the execution of all safety epidemiology activities at the global level.

The Real-World Evidence (RWE) function at Gilead aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. Success in this role requires a strong track record in the design and conduct of epidemiologic studies, direct expertise in use of RWE and application of adequate and contemporary analytical methods across drug development, including pediatrics and post-authorization phase of the product development and commercialization processes, and the ability to manage efforts and resources in a cross-functional matrix setting.

Duties & Responsibilities:

• Responsible for the development, execution, and communication of specified RWE safety / non-experimental studies for 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 RWE safety and PAS protocols and analysis plans developed internally and externally.
• Collaborate and coordinate safety, pediatrics, and PAS activities with RWE Virology Product teams.
• Employ robust scientific methods for the timely execution of safety, pediatrics, and PAS strategy in alignment with pipeline / lifecycle management objectives.
• Lead or contribute to a team of observational research scientists within a matrix organization to deliver, within time, budget, and quality standards, RWE safety / PAS 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.
• Communicate effectively about the utility of RWE across the product lifecycle and contribute to the use of study results to support internal and external decisions.
• Communicate 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 teams and initiatives.
• Leverage close collaborations with quantitative functions within CDS (e.g., Biostatistics, Bioinformatics), 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.
• Identify the need for and contribute directly to the development of processes and delivery of training documents aimed at increasing the efficiency, quality, and impact of functional activities.
• Mentor junior epidemiologists to ensure competence in epidemiologic skills and knowledge.

Requirements:

• Doctoral degree (e.g., PhD, MD, ScD, PharmD) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 8+ years of relevant, post‑graduation experience with doctoral training OR Master’s degree (e.g., MSc) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution with 10+ years of relevant experience with Master’s training.
• 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.
• Experience designing and conducting observational research, including protocol, statistical analysis plan, and study report development.
• Solid working knowledge of global regulatory guidelines pertaining to RWD and RWE studies, especially PAS.
• Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
• 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.
• Experience managing vendor relationships, leading studies, projects and people in a matrix setting.
• Demonstrated ability to function with autonomy and develop productive cross‑functional collaborations.
• Ability to manage priorities, resources, and performance targets, in a changing environment.
• Well‑developed cross‑cultural sensitivity.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account.

Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit select and employ the most qualified persons available for positions throughout the Company.