Director, Real-World Evidence Oncology (Post Authorization Studies)
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 24, 2022
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
- 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
- Employ robust scientific methods for the timely execution of
PAS strategy in alignment with pipeline/lifecycle management
- 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
- 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
- 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
- Preference for understanding of the Oncology therapeutic area,
including disease knowledge, current treatment practice and
guidelines, pertinent clinical trial endpoints and safety
- Experience designing and conducting observational research,
including protocol, statistical analysis plan, and study report
- 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
- 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
- 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.
Keywords: Gilead Sciences, Inc., San Mateo , Director, Real-World Evidence Oncology (Post Authorization Studies), Executive , San Mateo, California
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