Senior Medical Director - Patient Safety

The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head, collaborating with the development medical lead to set oncology program strategy. PST lead responsible for one or more products and ensuring safety through the product lifecycle (surveillance, signal detection, validation and assessment, risk assessment and mitigation strategies, tox management, etc.) with other safety team members. Collaborates with PK/toxicology leads, regulatory and clinical development leads, and medical affairs to guide dose selection and regimen, inclusion/exclusion criteria, and safety monitoring for first clinical trials and PMOS. Interprets pharmacovigilance regulations supporting patient safety activities and leads 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 knowledge
- 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 components)
- Apply regulatory guidance for safety surveillance and PV document authorship
- Analyze and interpret aggregate safety data; communicate to cross-functional teams and leadership
- Write/review/provide input on technical documents
- Lead periodic report strategy (DSURs, PSURs, PADERs)
- Implement risk management strategies for assigned products
- Engage, coach, mentor teams; adapt in fast pace environment

Qualifications:
- MD/DO with 2+ years internal medicine residency (patient management required)
- 2–5 years pharmacovigilance/clinical development in pharma industry
- Prior regulatory submissions support (IND/BLA) required
- Oncology patient safety experience required
- PhD or Clinical Pharmacology fellowship preferred
- Ability to analyze clinical/epidemiological data and present recommendations; write/review technical documents; collaborate and lead cross-functional teams

Benefits (if eligible): paid time off; medical/dental/vision insurance; 401(k); long-term incentive program participation.

Application instructions: not provided.