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Job description
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
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Worksite address
florham park, NJ, 07932, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.