Director- Real World Evidence RWE Oncology Pharmacoepidemiology and Safety

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Job Description

The RealWorld 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 RealWorld Data (RWD) to help transform innovations to lifechanging medicines for patients. The Director RWE Oncology reports to the Senior Director RWE Oncology Pharmacoepidemiology and Safety Lead and contributes to the development and 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 subteams 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 RealWorld 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 crossfunctional matrix setting.

Job Description:

Duties & Responsibilities:

• Serve as the single point of accountability for the timely development and communication of specified pharmacoepidemiology and safety studies for individual products and their pipeline/lifecycle indications in Oncology.
• Provide functional perspective and subjectmatter 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 postauthorization 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 postapproval 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 crossfunctional 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 Masters degree (e.g. MSc MPH) in Epidemiology or related discipline such as Outcomes Research Medicine Biostatistics from an accredited institution with an extensive experience.
• Direct experience with different applications of RWE including in support of earlystage 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 crossfunctional collaborations.
• Ability to manage priorities resources and performance targets.
• Welldeveloped crosscultural sensitivity.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

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