Director- Real World Evidence (RWE) Oncology
(Pharmacoepidemiology and Safety) United Kingdom - Cambridge
Pharmacovigilance & Epidemiology Regular Job Description At
Gilead, we’re creating a healthier world for all people. For more
than 35 years, we’ve tackled diseases such as HIV, viral hepatitis,
COVID-19 and cancer – working relentlessly to develop therapies
that help improve lives and to ensure access to these therapies
across the globe. We continue to fight against the world’s biggest
health challenges, and our mission requires collaboration,
determination and a relentless drive to make a difference. Every
member of Gilead’s team plays a critical role in the discovery and
development of life-changing scientific innovations. Our employees
are our greatest asset as we work to achieve our bold ambitions,
and we’re looking for the next wave of passionate and ambitious
people ready to make a direct impact. We believe every employee
deserves a great leader. People Leaders are the cornerstone to the
employee experience at Gilead and Kite. As a people leader now or
in the future, you are the key driver in evolving our culture and
creating an environment where every employee feels included,
developed and empowered to fulfil their aspirations. Join Gilead
and help create possible, together. Job Description The Real-World
Evidence (RWE) function at Gilead is part of the Clinical Data
Sciences (CDS) department 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 Director, RWE Oncology reports to the Senior
Director, RWE Oncology Pharmacoepidemiology and Safety Lead and
contributes to the development and execution of the RWE strategy in
support of an Oncology Franchise through oncology product
development and commercialization. The incumbent will serve as an
RWE pharmacoepidemiology and safety subject matter expert for
Oncology interacting with pertinent indication sub-teams of the
Global Development Team (s) (GDT) for the Franchise(s) and a
strategic partner to clinical development, medical, patient safety,
and commercial teams by the generation of RWE at the global level.
The Director, Real-World Evidence (RWE) Oncology
Pharmacoepidemiology and Safety 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 post authorization safety studies,
rapid analyses to address ad hoc epidemiologic queries /analyses,
direct expertise in use of RWE at different stages of the product
development and commercialization processes, including early- stage
clinical development, 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 timely development, execution, and communication of specified
pharmacoepidemiology and safety studies for individual products and
their pipeline/lifecycle indications in Oncology. - 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 Pharmacovigilance and Safety analysis
plans developed internally and externally. - Ensure collaboration
and coordination of Pharmacovigilance and Safety projects within
RWE Oncology Product teams. - Work 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. -
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
extensive experience. - 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. -
Preference for understanding of the Oncology therapeutic area,
including disease knowledge, current treatment practice and
guidelines, pertinent clinical trial endpoints and safety outcomes.
- 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.
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