Associate Director, Real World Evidence Oncology
Company: Gilead Sciences
Location: San Mateo
Posted on: May 7, 2022
The Associate Director, Real-World Evidence (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
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 products in Franchise(s) in
- 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
- 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
- Mentor junior epidemiologists and RWE analysts to ensure
competence in epidemiologic skills and knowledge.
- 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 2 years (PhD) or 8 years (MS) of
- 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
- 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
- Demonstrated ability to function with autonomy and develop
productive cross-functional collaborations.
- Ability to manage priorities, resources, and performance
- Well-developed cross-cultural sensitivity.
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with Disabilities Act of 1990, applicants who require accommodation
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Keywords: Gilead Sciences, San Mateo , Associate Director, Real World Evidence Oncology, Executive , San Mateo, California
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