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Gilead Sciences, Inc.
Uxbridge, CA, United Kingdom (on-site)
1 day ago
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Gilead Sciences, Inc.
Uxbridge, California, United Kingdom (on-site)
1 day ago

Description



Senior Director, RWE Oncology Franchise Lead (Early Development)
United Kingdom - Uxbridge

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. Gileads 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 companys five core values. Thats 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

For Current Gilead Employees and Contractors:

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

Job Description


Position Description

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, Early Development Franchise Lead reports to the Executive Director, RWE Therapeutic Area (TA) Head-Oncology and is accountable for the development and execution of the RWE strategy in support of one or more Oncology Franchises under development. The incumbent will serve as the key RWE subject matter expert within the Global Development Team (GDT) for the product(s) within an Oncology Franchise and all its indications across the development lifecycle and serve as a strategic partner to clinical development, medical, and commercial teams to ensure excellence in the generation and use of RWE at the global level.

The SD, RWE Oncology Franchise Lead will oversee a portfolio of observational research, which may include people management, and ensure the timeliness, quality, and utility of RWE required by internal and external stakeholders (e.g. Regulators), as well as advise on methodological approaches in support of payer and provider interactions.

Success in this role requires excellence in design and conduct of epidemiologic studies/analyses, direct expertise in use of RWE at early stages of the product Oncology Franchise development process, and the ability to lead and manage cross-functional efforts and resources.

Duties & Responsibilities
  • Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting early-stage clinical development evidence requirements for a specific Oncology Franchise and its pipeline/lifecycle indications in Oncology.
  • Ensure the use of robust scientific methods and fit-for-purpose data resources for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.
  • Provide the functional perspective and subject-matter expertise, especially regarding regulatory use of RWE, as a member of the Early Development Oncology Franchise GDTs.
  • Deliver, within time, budget, and quality standards, proactive RWE generation 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 and comparative safety and effectiveness research.
  • Communicate effectively about the utility of RWE across the product Oncology Franchise lifecycle and drive use of study/analysis results to support internal and external decisions across the Franchise.
  • Ensure expert communication of observational research results, including development of pertinent sections of regulatory documents, publications, white papers, press releases, etc.
  • Oversee 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 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 in Research, Clinical Research, 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 significant years of relevant, post-graduation experience; preference for some 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 early-stage clinical development and regulatory approvals.
  • Demonstrated understanding of the Oncology therapeutic area, including disease knowledge, current treatment practice and guidelines, pertinent clinical trial endpoints and safety outcomes.
  • Experience leading, coaching, and managing people.
  • 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.


Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively \\"Gilead\\" or the \\"Company\\") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


For Current Gilead Employees and Contractors:


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


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Senior-Director--RWE-Oncology-Franchise-Lead--Early-Development-_R0032636-1







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Job Information

  • Job ID: 68057897
  • Workplace Type: On-Site
  • Location:
    Uxbridge, California, United Kingdom
  • Company Name For Job: Gilead Sciences, Inc.
  • Position Title: Senior Director, RWE Oncology Franchise Lead (Early Development)
  • Job Function: Industry Research
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