Senior Medical Director, Immunology, Global Patient Safety
Core
Lead patient safety strategy for immunology products across the lifecycle, managing pharmacovigilance, signal detection, and risk mitigation.
Role type
Senior Medical Director (Patient Safety)
Builds
Safety strategies, regulatory submissions (NDA/sNDA), and risk management plans for immunology therapeutics.
Domain
Pharmaceutical / Biotechnology / Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Patient safety strategy, pharmacovigilance, regulatory guidance interpretation, clinical data analysis, epidemiological analysis, risk management planning, technical document authorship, cross-functional leadership
Preferred skills
Immunology/Internal medicine expertise, leadership in clinical development, experience with drug-device combinations
Technologies
DSURs, PSURs, PADERs, RMPs, NDA/sNDA
Responsibilities
Analyze aggregate safety data and communicate findings to leadership; Lead strategy for pharmacovigilance documents and regulatory submissions; Apply regulatory guidance for safety surveillance; Interpret pharmacology and toxicology data; Write and review technical safety documents; Oversee periodic safety reports; Implement risk management strategies; Mentor team members.
Seniority
Senior, hands-on IC with leadership responsibilities