In this role, the clinician provides medical safety oversight for oncology clinical development programs, with a focus on assessing adverse events, serious adverse events, safety signals, and overall benefit-risk throughout the trial and product life cycle. The work centers on safety strategy for assigned studies and portfolios, including protocol input, investigator training, regulatory interactions, and safety contributions to clinical and regulatory documents. This is a strategic pharmacovigilance position with substantial cross-functional collaboration across safety scientists, study teams, and regulatory partners.
Key Responsibilities
- Oversee safety monitoring, signal management, and benefit-risk assessment for assigned products and programs.
- Conduct medical review of safety data, including adverse events of special interest and serious adverse events.
- Provide input on clinical trial protocols and safety-related follow-up actions.
- Prepare and review safety content for DSURs, investigator brochures, clinical study reports, and other regulatory documents.
- Train investigators and mentor safety physicians and safety scientists.
- Present safety information and interact with regulatory authorities on assigned products.
- Support due diligence activities and alliance management for licensing, acquisition, and partner collaborations.
- Ensure compliance with GCP, applicable laws, and global and local regulatory reporting requirements.
Required
- Medical degree or internationally recognized equivalent.
- Extensive experience in drug safety or pharmacovigilance within the biopharmaceutical or biotechnology industry.
- Experience supporting innovative drug development and regulatory submissions such as BLA/MAA.
- Experience working with regulatory agencies on development strategies, preferably for oncology products.
- Experience implementing GCP standards and safety reporting requirements in clinical trials.
- Demonstrated ability to work effectively in a matrix and multidisciplinary environment.
Preferred
- MD/PhD or certified training in a relevant medical discipline.
- Experience in immuno-oncology or inflammation therapeutic areas.
- Advisory committee experience.
- Exposure to U.S. regulatory agency interactions.
Benefits & Perks
- Full-time position.
- Competitive pay range with annual bonus and equity eligibility.
- Comprehensive benefits package for eligible employees working 30+ hours per week.
- Medical, dental, and vision insurance.
- 401(k) plan with company match.
- Paid time off, including vacation, sick leave, holidays, floating holidays, and year-end shutdown.
- Professional development programs and tuition reimbursement.
- Commuting allowance and subsidized parking.