Senior Medical Director - Patient Safety

The Product Safety Team (PST) lead for late-stage oncology products, under the Group Lead/TA Head, collaborating with development medical leads to set oncology program safety strategy. Responsible for one or more products and ensuring patient safety through the product lifecycle (surveillance, signal detection, validation/assessment, risk assessment and mitigations, tox management, etc.) with cross-functional safety teams. Collaborates with PK/toxicology leads, regulatory and clinical development leads, and medical affairs on dose selection/regimen, inclusion/exclusion criteria, and safety monitoring for first-in-clinical trials and PMOS. Interprets pharmacovigilance regulations and leads safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label/label updates, and RMPs.

Responsibilities:
- Safety surveillance using pharmacology, chemistry, and non-clinical toxicology
- Safety surveillance for pharmaceutical/biological/drug–device combined products
- Set strategy for pharmacovigilance documents (medical safety assessments, regulatory responses, risk management plans, safety component of NDA/sNDA submissions)
- Apply regulatory guidance for safety surveillance and PV document authorship
- Analyze/interpret aggregate safety data; communicate internally, to leadership, and externally
- Write/review/provide input on technical documents
- Lead periodic report strategy (DSURs, PSURs, PADERs, etc.)
- Implement risk management strategies for assigned products
- Engage, coach, and mentor team; co-author publications; adapt in fast pace 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
- Prior regulatory submission support (IND/BLA) (required)
- Oncology patient safety experience (required)
- Ability to analyze clinical/epidemiological data; present recommendations internally/externally; write/review technical documents; lead cross-functional teams

Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility