Sr Manager RWE- Virology

Location
Foster City, CA
Posted
Jan 25, 2022
Ref
2800821
Discipline
Science/R&D, Virology
Required Education
Masters Degree/MBA
Position Type
Full time
Sr Manager RWE- Virology
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


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 Senior Manager, RWE Virology is part of a team led by the RWE Virology Product Lead and supports the execution of the RWE strategy in support of an Virology product(s) through development and commercialization. The incumbent will serve as an RWE tactical contributor within pertinent indication sub teams of the Global Development Team (GDT) for the product(s) and support RWE generation used by clinical development, medical, and commercial teams at the global level.

The Senior Manager, RWE Virology will support the design and delivery of RWE required by internal stakeholders and regulators, ensuring timeliness and quality.

Success in this role requires a deep understanding of observational research methods, a track record in the conduct of epidemiologic studies/analyses, and the ability to collaborate effectively in a matrix setting.

Duties & Responsibilities
  • Support 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
  • Support the identification of fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives
  • Support the generation, within time, budget, and quality standards, of 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 of 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)
  • 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, MD, ScD, PharmD) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of one (1) year of relevant, post-graduation experience; or a Master's degree (e.g. MSc, MPH) with a minimum of six (6) years of relevant, post-graduation experience. Preference for at least half of that experience to be in the biopharmaceutical industry.
  • 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 therapeutic area is preferred
  • Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations
  • Ability to manage priorities and performance targets
  • Well-developed cross-cultural sensitivity

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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