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Gilead Sciences, Inc. Director, Real-World Evidence Virology (Post Authorization Studies Lead) in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

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Job Description

Site Locations Include: Foster City, CA (preferred) | Raleigh, NC | Morris Plains, NJ | Seattle, WA | Washington, D.C. | Stockley Park, UK

Duties & Responsibilities

  • Responsible for the development, execution, and communication of specified post-authorization/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 PAS protocols and analysis plans developed internally and externally.

  • Collaborates and coordinates PAS activities with RWE Virology Product teams.

  • Employ robust scientific methods for the timely execution of 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, post-authorization studies 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.

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 eight (8) years of relevant, post-graduation experience with doctoral training, or ten (10) years with Master’s training; preference for a minimum of four (4) years of that experience to be 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.

  • Experience designing and conducting observational research, including protocol, statistical analysis plan, and study reportdevelopment.

  • Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.

  • Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.

  • A 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 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.

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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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For Current Gilead Employees and Contractors:

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Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, and Australia employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.

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