Gilead is looking to solve the problem of developing therapies for diseases such as HIV, viral hepatitis, COVID-19, and cancer, and ensuring access to these therapies across the globe.
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, with a minimum of twelve (12) years of relevant, post-graduation experience;
- 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 early-stage clinical development and regulatory approvals.
- Demonstrated understanding of the Virology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes. Specific expertise in HIV epidemiology strongly preferred.
- Experience with RWE at different stages of the product development and commercialization processes
- Ability to lead and manage cross-functional efforts and resources
- Exceptional stakeholder management
- Experience with epidemiologic studies/analyses
Responsibilities
- Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development through post-authorization evidence needs for the HIV Treatment Product Area and its pipeline/lifecycle indications.
- Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT/PST objectives.
- Lead a team of observational research scientists to deliver, within time, budget, and quality standards, proactive RWE generation 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 voluntary post-approval studies.
- Provide functional perspective and subject-matter expertise, especially regarding strategic and regulatory use of RWE, to the product GDT, either as a member or via a delegate.
- Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
- Ensure expert communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers, press releases, etc.
- Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
Other
- Experience leading, coaching, and managing people in a global 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.
