Position Description
The Senior Director, EpiRWE Oncology Franchise Lead in Early Development leads development and execution of an RWE strategy for one or more Oncology franchises.
Duties & Responsibilities
- Single point of accountability for global EpiRWE strategy supporting early-stage clinical development evidence needs across an Oncology franchise and its pipeline indications.
- Ensure robust scientific methods and fit-for-purpose data resources aligned to the clinical development plan and cross-functional objectives.
- Provide regulatory-facing epidemiology/RWE subject-matter expertise (EMT member; DET situational member).
- Lead proactive EpiRWE generation (e.g., natural history, population characterization, treatment patterns/unmet need, external comparators, benchmarking outcomes, comparative safety/effectiveness).
- Drive use of EpiRWE results across internal/external decisions; communicate observational research outcomes (regulatory document sections, publications, white papers, press releases).
- Oversee epidemiology sections for regulatory documents globally (e.g., RMP, orphan/breakthrough designations, Pediatric Investigation Plan, query responses, advisory briefing documents).
- Represent EpiRWE in cross-functional initiatives and external organizations (associations, societies, regulatory working groups).
- Collaborate with quantitative functions (Biostatistics, Bioinformatics, Clinical Pharmacology) and teams across Research, Clinical Research, Medical Affairs, and Global Value & Access.
- Identify process/training gaps to improve efficiency, quality, and impact.
Requirements
- Doctoral (PhD/MD/ScD/PharmD) and/or Masterβs (MSc) in Epidemiology or related field; minimum 12 years relevant post-graduation experience (preferred 6+ in biopharmaceutical industry).
- Publication track record in observational study design/analysis/interpretation; direct experience with Epidemiology/RWE for early-stage development and regulatory approvals.
- Demonstrated oncology therapeutic area understanding (disease, treatment practice/guidelines, trial endpoints, safety outcomes).
- Ability to work autonomously, collaborate cross-functionally, manage priorities/resources in changing environments, and communicate proactively.
- Cross-cultural sensitivity.
Compensation/Benefits (as stated)
- Salary range: Bay Area $261,375β$338,250; Other US Locations $237,575β$307,450; may include discretionary bonus and long-term incentives; paid time off and medical/dental/vision/life insurance.
Application Instructions
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.