Director, Real-World Evidence (RWE)- Virology

Location
Foster City
Salary
See job description.
Posted
August 31 2021
Ref
R0021803
Discipline
Life Sciences, Virology
Position Type
Full Time
Organization Type
Pharma


Director, Real-World Evidence (RWE)- Virology
United States - California - Foster CityUnited States - District of Columbia - WashingtonUnited States - New Jersey - Morris PlainsUnited States - North Carolina - RaleighUnited 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


The Director, Real-World Evidence (RWE)- Virology 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 Virology.
  • 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.


Requirements:
  • Doctoral degree (e.g. PhD, MD, ScD, PharmD) and/or 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 8 years (PhD) or 10 years (MS) of relevant experience. Preference for a minimum of six (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 Virology 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.

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 careers@gilead.com 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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