Director, Real-World Evidence (RWE)- Oncology
Director, Real-World Evidence (RWE)- Oncology
United States - California - Foster CityUnited Kingdom - UxbridgeUnited States - District of Columbia - WashingtonIreland - DublinUnited States - New Jersey - Morris PlainsUnited States - North Carolina - RaleighUnited Kingdom - CambridgeUnited States - Washington - Seattle
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
*** Position may be based onsite at the following locations: Foster City, CA, Morris Plains, NJ, Seattle WA, Washington DC, Raleigh, NC, Cambridge, UK, Stockley Park, UK and Dublin, Ireland.
The Director, RWE Oncology will design and deliver RWE required by internal stakeholders and regulators, ensuring timeliness, quality, and utility, as well as advise on methodological approaches including support of payer and provider interactions.
Success in this role requires a strong track record in the design and conduct of epidemiologic studies/analyses, direct expertise in use of RWE at different stages of the product development and commercialization processes, and the ability to manage effort and resources in a cross-functional, matrix setting.
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 and post-authorization evidence requirements for one or more pipeline/lifecycle indications for product(s) in Oncology.
- Employ robust scientific methods and fit-for-purpose data for the timely execution of the RWE strategy, in alignment with the clinical development plan and broader GDT objectives.
- Generate, within time, budget, and quality standards, 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.
- Communicate effectively about the utility of RWE across the product lifecycle and drive use 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).
- 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 in Clinical Research, Patient Safety, 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 aimed at increasing the efficiency, quality, and impact of functional activities.
- Mentor junior epidemiologists and RWE analysts to ensure competence in epidemiologic skills and knowledge.
- Doctoral degree (e.g. PhD, MD, ScD, PharmD) with a minimum of 8 years of relevant, post-graduation experience; preference for a minimum of 6 years of that experience to be in the biopharmaceutical industry.
- Master's degree (e.g. MSc, MPH) in Epidemiology or related discipline, such as Outcomes Research, Medicine, Biostatistics from an accredited institution, with a minimum of 10 years of relevant, post-graduation experience; preference for a minimum of 6 years of that experience to be in the biopharmaceutical industry.
- Direct experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and/or safety commitments.
- Experience designing and conducting 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 track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
- Knowledge of the Oncology therapeutic area.
- Experience leading studies and projects in a matrix setting.
- Demonstrated ability to function with autonomy and develop productive cross-functional collaborations.
- Ability to manage priorities, resources, 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 firstname.lastname@example.org for assistance.
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