Director, RWE Virology Safety Epidemiology

Role Summary

As a Director in Real-World Evidence at Gilead you will lead the epidemiology and safety RWE programs for Virology, directing observational studies across the product lifecycle, and collaborating with cross-functional teams to meet safety and regulatory evidence needs. You will serve as the key subject-matter expert for Virology post-marketing commitments and pharmacoepidemiology activities, and manage a matrix team of researchers to deliver timely, high-quality RWE studies. Open to candidates at Foster City, Cambridge (UK), or Stockley Park (UK).

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.
• Collaborates and coordinates 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.
• Communicates 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.

Qualifications

• Required: 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
• Required: 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.
• Preferred: minimum of four (4) years of professional experience in the biopharmaceutical industry.
• 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. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.