Director, Real-World Evidence Oncology (Post Authorization Studies)

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 24, 2022

Job Description:

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 Oncology.
• 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 Oncology 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 Oncology 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 report development.
  • 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.For jobs in the United States: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 for assistance.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. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since 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 a reasonable accommodation. For more information about equal employment opportunity protections, please view the EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
    
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Keywords: Gilead Sciences, Inc., San Mateo , Director, Real-World Evidence Oncology (Post Authorization Studies), Executive , San Mateo, California