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For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
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. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Key Responsibilities:
The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) department within the Clinical Development organization and aims to unlock the power of Real-World Data (RWD) to help transform innovations to life-changing medicines for patients. The Associate Director, RWE Virology/Inflammation/Oncology is part of a team that reports to the RWE Virology/Inflammation/Oncology Product Lead and contributes to the development and execution of the RWE strategy in support of a Virology/Inflammation/Oncology product(s) through development and commercialization. The incumbent will serve as an RWE subject matter contributor within pertinent indication sub teams of the Global Development Team (GDT) for the product(s) and a partner to clinical development, medical, and commercial teams by the generation of RWE at the global level.
The Associate Director, RWE Inflammation will directly support the design of and be responsible for the delivery of RWE required by internal stakeholders and regulators, ensuring timeliness and quality, as well as advise on methodological approaches including support of payer and provider interactions.
Success in this role requires a demonstrated track record in the conduct of epidemiologic studies/analyses, experience in use of RWE at different stages of the product development and commercialization processes, and the ability to collaborate effectively in a cross-functional, matrix setting.
Duties & Responsibilities
Be responsible for the execution and communication of the global RWE strategy supporting early-stage clinical development and post-authorization evidence requirements for one or more pipeline/lifecycle indications for product(s) in Virology/Inflammation/Oncology.
Employ robust scientific methods and identify fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.
Generate, within time, budget, and quality standards, real-world evidence 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 post-authorization studies.
Ensure fulfillment of observational study conduct requirements, such as registration, ethical board approval, protocol, SAP, study report development, and disclosure.
Support the effective communication about the utility of RWE across the product lifecycle and use study/analysis results to support internal and external decisions.
Contribute to the communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers.
Contribute to timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents).
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 in Clinical Research, Patient Safety, Medical Affairs, and Global Value and Access to meet the evidence needs of regulators, payers, providers, and patients.
Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.
Requirements
Doctoral degree (e.g. PhD, ScD) in Epidemiology from an accredited institution, with a minimum of two (2) years of relevant, post-graduation experience; or a master’s degree (e.g. MSc, MPH) with a minimum of eight (8) years of relevant, post-graduation experience. Preference for at least half of that experience to be in the biopharmaceutical industry.
Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and/or safety commitments.
Experience contributing to the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.
Experience with secondary data analysis, including electronic medical record and/or medical claims databases, and with statistical analysis tools, such as SAS and R.
A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
Knowledge of the Virology/Inflammation/Oncology therapeutic area.
Experience supporting studies and projects in a matrix setting.
Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations.
Ability to manage priorities, resources, and performance targets.
Well-developed cross-cultural sensitivity.
Gilead Core Values:
Integrity (Doing What's Right)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
Inclusion (Encouraging Diversity)
About Gilead:
Gilead Science. Inc, is research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.