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Sr. Director, RWE - Oncology - PAS (Post Authorization Studies)

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 25, 2023

Job Description:

Sr. Director, RWE - Oncology - PAS (Post Authorization Studies)
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

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:

Please log onto your Internal Career Site to apply for this job.

Job Description

Sr. Director, RWE - Oncology - Post Authorization Studies (PAS)

Site Locations Include: Stockley Park, UK (preferred)
Will also consider candidate for offices located in Foster City, CA Raleigh, NC Seattle, WA Washington, D.C. and Morris Plains, NJ

Job Description Summary

The Real-World Evidence (RWE) function at Gilead is part of the Clinical Data Sciences (CDS) group 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 Director, RWE Oncology Post Authorization Studies (PAS) Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head-Oncology and has primary accountability for the execution of post authorization and other non-experimental studies, both mandatory and voluntary, in support of Oncology products for Gilead and Kite. The incumbent will serve as the key PAS subject matter expert for Oncology and serve as a strategic partner to the RWE Oncology Product Leads and cross-functional stakeholders to ensure excellence in the execution of PAS at the global level.

The SD, RWE Oncology PAS Lead will oversee a team of RWE scientists within a matrix organization and advocate for the appropriate level of resources to ensure the timeliness, quality, and utility of PAS required by internal and external stakeholders (including regulators). Success in this role requires excellence in communication and stakeholder management, design and conduct of epidemiologic studies, direct expertise in use of RWE and application of appropriate and contemporary analytical methods at different stages of the product development and commercialization processes, and the ability to lead and manage cross-functional efforts and resources.

The SD, RWE Oncology PAS lead will be responsible for maintaining an up to date overview of the mature oncology products in Gilead and Kite and communicating on time and effectively with the SD Franchise Oncology leads in RWE to determine which studies are likely to be in consideration and plan for the development of PAS studies in good time. The SD RWE Oncology lead will also be required to work effectively with the Global Medical Affairs leads and local country Medical Affairs leads to ensure smooth set up of studies and ensure good communication throughout study timeline.

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

    Duties & Responsibilities
    • Serve as the primary point of accountability for the timely 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.
    • Ensure collaboration and coordination of PAS activities with RWE Oncology Product teams
    • Lead 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 and drive use of study results to support internal and external decisions.
    • Ensure expert communication of 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 initiatives and external organizations, such as industry associations, professional societies, or regulatory working groups.
    • Foster 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.
    • Actively identify the need for the development of processes or gaps in training documents aimed at increasing the efficiency, quality, and impact of functional activities.
      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 twelve (12) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
      • 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.
      • Preference for understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
      • Solid working knowledge of regulatory guidelines pertaining to RWD and RWE studies, especially post-authorization studies.
      • Experience leading, coaching, and managing people in a global setting.
      • Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations.
      • Ability to manage priorities, resources, and performance targets, in a changing environment.
      • Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions.
      • 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., Canada, Australia, Singapore, and Hong Kong 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 . click apply for full job details

Keywords: Gilead Sciences, Inc., San Mateo , Sr. Director, RWE - Oncology - PAS (Post Authorization Studies), Healthcare , San Mateo, California

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