Senior Medical Director - Patient Safety
Core
Lead patient safety strategy for late-stage oncology products, managing surveillance, signal detection, and risk management from pre-clinical through NDA submission.
Role type
Senior Medical Director (Patient Safety)
Builds
Safety components for regulatory submissions (NDA/sNDA), Risk Management Plans (RMPs), and periodic safety reports (DSURs/PSURs).
Domain
Pharmaceutical / Biotechnology, Oncology, Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance strategy, regulatory submission support (IND/BLA), oncology patient safety, aggregate safety data analysis, risk management planning, medical safety assessments
Preferred skills
Clinical Pharmacology fellowship, PhD, internal medicine residency with patient management experience
Technologies
DSURs, PSURs, PADERs, RMPs, NDA/sNDA
Responsibilities
Lead pharmacovigilance documents and regulatory responses, analyze aggregate safety data, implement risk management strategies, oversee periodic safety reports, collaborate on dose selection and trial criteria
Seniority
Senior, hands-on IC
