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.
We are seeking a Director, RWE Inflammation to contribute to the development and execution of the RWE strategy in support of an Inflammation product(s) through development and commercialization. The incumbent will serve as an RWE subject matter expert for the product(s) on Gilead’s lifecycle management teams, including the Development Evidence Team (DET) and/or Early Molecule Teams (EMT) or pertinent subteams; and a partner to clinical development, medical, and commercial teams by the generation of RWE at the global level.
The Director, RWE Inflammation 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. The Director, RWE Inflammation reports to the RWE Inflammation Product Lead.
Duties & Responsibilities
- Serve as the single point of accountability for the development, execution, and communication of the global RWE strategy supporting clinical development and regulatory submissions for one or more pipeline/lifecycle indications for product(s) in Inflammation.
- 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 DET/EMT objectives.
- Generate 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/external controls (including multi-database studies using EHR/claims and, as needed, chart review/medical record abstraction), benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies.
- Ensure fulfillment of observational study conduct and execution requirements, such as study planning and operationalization (e.g., feasibility, data sourcing, vendor oversight, and data governance), registration, ethics/IRB review as applicable, protocol, statistical analysis plan (SAP), study report development, disclosure, and inspection/audit readiness.
- Communicate effectively about the utility of RWE across the product lifecycle and drive use of study/analysis results to support internal and external decisions.
- Ensure fulfillment of observational study conduct and execution requirements, such as study planning and operationalization (e.g., feasibility, data sourcing, vendor oversight, and data governance), registration, ethics/IRB review as applicable, protocol, statistical analysis plan (SAP), study report development, disclosure, and inspection/audit readiness.
- Contribute to timely and appropriate development of epidemiological and RWE-related components of regulatory deliverables for agencies worldwide, ensuring clear documentation, traceability, and alignment with internal governance and applicable data standards.
- Represent the RWE function in internal cross-functional teams and initiatives.
- Ensure fulfillment of observational study conduct and execution requirements, such as study planning and operationalization (e.g., feasibility, data sourcing, vendor oversight, and data governance), registration, ethics/IRB review as applicable, protocol, statistical analysis plan (SAP), study report development, disclosure, and inspection/audit readiness.
- Ensure fulfillment of observational study conduct and execution requirements, such as study planning and operationalization (e.g., feasibility, data sourcing, vendor oversight, and data governance), registration, ethics/IRB review as applicable, protocol, statistical analysis plan (SAP), study report development, disclosure, and inspection/audit readiness.
- Ensure fulfillment of observational study conduct and execution requirements, such as study planning and operationalization (e.g., feasibility, data sourcing, vendor oversight, and data governance), registration, ethics/IRB review as applicable, protocol, statistical analysis plan (SAP), study report development, disclosure, and inspection/audit readiness.
Requirements
- Doctoral degree (e.g. PhD, ScD) and/or Master’s degree (e.g. MSc, MPH) in Epidemiology from an accredited institution, with a minimum of eight (8) years of relevant, post-graduation experience; preference for a minimum of six (6) years of that experience to be in the biopharmaceutical industry.
- Direct experience using RWE for regulatory-facing evidence generation (e.g., support of regulatory submissions/label expansions, Health Authority interactions, and/or post-authorization safety/effectiveness commitments).
- Experience designing and conducting observational research, including protocol, SAP, and study report development, with comfort operating under regulatory-grade documentation and compliance expectations (e.g., study registration/disclosure, ethics/IRB requirements, inspection/audit readiness, and robust traceability from data to analysis to reporting).
- Experience with secondary data analysis using multi-database real-world data (e.g., EHR and/or medical claims) and familiarity with data collection approaches that complement RWD (e.g., chart review/medical record abstraction), including data tokenization, endpoint operationalization, and data quality assessment
- Experience developing external comparators/external controls in support of clinical development (e.g., external control trials, hybrid designs, or synthetic control arms), including multi-source data integration, prespecified endpoint definitions aligned to the trial, and proactive engagement with cross-functional partners (Clinical, Biostats, Data Management, Regulatory, Safety).
- Working knowledge of clinical trial data standards and submission expectations and experience partnering to translate RWD/RWE outputs into fit-for-purpose, well-documented deliverables (e.g., mapping/specifications, metadata, traceability, and quality checks) for internal governance and/or regulatory use.
- Demonstrated ability to operationalize complex observational studies in a regulated environment (e.g., vendor oversight, privacy/security considerations, data provenance, SOP/working instruction development, and cross-functional governance)
- A track record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
Minimum Required Education and Years of Experience
- Bachelor's Degree and Twelve Years’ Experience OR
- Masters' Degree and Ten Years’ Experience OR
- PhD and Eight Years’ Experience
Preferred Education and Years of Experience
- Doctoral degree (e.g. PhD, ScD) and/or Master’s degree (e.g. MSc) in Epidemiology from an accredited institution, with a minimum of twelve (10) years of relevant, post-graduation experience; preference for a minimum of six (4) years of that experience to be in the biopharmaceutical industry.
People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
