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 Paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility #J-18808-Ljbffr AbbVie