Senior Medical Director-Late Stage Oncology

The Product Safety Team (PST) lead for late stage oncology products will collaborate with development medical leadership to set oncology program strategy. Responsible for product safety through the product lifecycle (e.g., surveillance, signal detection, validation/assessment, risk assessment/mitigation, tox management) with safety team members (safety scientists/architects/PM and cross-functional colleagues). Collaborate with PK/toxicology leads, regulatory/clinical development, and medical affairs to guide dose selection and regimen, inclusion/exclusion criteria, and safety monitoring for first-in-clinical trials and PMOS. Interpret pharmacovigilance regulations; lead safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label updates, and RMPs.

Responsibilities:
- Conduct safety surveillance using pharmacology/chemistry/non-clinical toxicology
- Lead safety surveillance for pharmaceutical/biological/drug-device combined products
- Set strategy for pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety components)
- Apply regulatory guidance for safety surveillance and PV document authorship
- Analyze/interpret aggregate safety data and communicate to cross-functional teams/executives
- Write/review technical documents
- Oversee periodic reports (DSURs/PSURs/PADERs)
- Implement risk management strategies for assigned products
- Coach/mentor teams; participate in initiatives/publications

Qualifications:
- MD/DO with 2+ years internal medicine residency patient management experience (required); PhD or Clinical Pharmacology fellowship preferred
- 5–8 years pharmacovigilance (PST lead-equivalent) / clinical development in pharma (required)
- Oncology experience strongly preferred
- Ability to analyze/guide clinical and epidemiological data; present recommendations; write/review technical documents; lead cross-functional teams

Benefits (if applicable to this role section): paid time off; medical/dental/vision insurance; 401(k); short-term and long-term incentive programs.