Director, RWE Virology Safety Epidemiology
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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 ensure access to these therapies across the globe. We continue to fight the world’s biggest health challenges, requiring collaboration, determination, and a relentless drive to make a difference.
Duties & Responsibilities
* 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 be 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, partnering with the RWE Virology Product teams and cross‑functional stakeholders to ensure excellence in execution of all safety epidemiology activities at the global level.
* Develop, execute, and communicate specified RWE safety/non‑experimental studies for individual products and 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 aligned 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 patient registries, natural history studies, drug utilization studies, 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) and 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
* 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; ensuring employees receive 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; providing the support needed to remove barriers and connect their team to the broader ecosystem.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit and select the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to compensation, benefits, transfers, layoffs, returns from layoffs, company‑sponsored training, education assistance, social and recreational programs are administered on a non‑discriminatory basis (i.e., without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees And Contractors: Please apply via the Internal Career Opportunities portal in Workday.
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