Senior Medical Director-Late Stage Oncology
Core
Lead product safety strategy and pharmacovigilance for late-stage oncology products throughout the product lifecycle.
Role type
Senior Medical Director (Product Safety)
Builds
Safety components for pre-NDA and NDA/sNDA submissions, risk management plans, and regulatory responses.
Domain
Pharmaceutical industry, Oncology, Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance strategy, aggregate safety data analysis, regulatory guidance application, technical document authorship, risk management strategy implementation, cross-functional team leadership, clinical data analysis
Preferred skills
Clinical Pharmacology fellowship, Oncology experience, patient management experience
Technologies
DSURs, PSURs, PADERs, RMPs
Responsibilities
Lead and set strategy for key pharmacovigilance documents, analyze and interpret aggregate safety data, oversee periodic safety reports, implement risk management strategies, guide dose selection and regimen for clinical trials, co-author publications
Seniority
Senior, hands-on IC with mentorship