Senior Medical Director- Early Development 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 ensuring safety through the product lifecycle (e.g., surveillance, signal detection, validation/assessment, risk assessment and mitigations, tox management) with the safety team and cross-functional partners (PK/toxicology, regulatory, clinical development, medical affairs) to guide dose selection/regimen, eligibility criteria, and safety monitoring for clinical trials and PMOS. Interprets pharmacovigilance regulations and leads safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, and RMPs.

Responsibilities:
- Conduct safety surveillance using pharmacology, chemistry, and non-clinical toxicology
- Lead safety surveillance for pharmaceutical/biological/drug-device combined products
- Set strategy for key pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, NDA/sNDA safety component)
- Apply regulatory guidance for safety surveillance and PV document authorship
- Analyze and interpret aggregate safety data and communicate to teams/executive leadership/external stakeholders
- Write/review/provide input on technical documents
- Lead periodic report strategy (DSURs, PSURs, PADERs, etc.)
- Implement risk management strategies for assigned products
- Engage/coaching/mentoring; collaborate in fast-paced environment

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