Medical Director, Safety Physician - Oncology
Core
Lead clinical safety strategy and risk management for AstraZeneca-MedImmune oncology drug projects from development through post-marketing.
Role type
Senior Medical Director, Safety Physician (Oncology)
Builds
Safety governance frameworks, risk minimization plans, and regulatory safety documentation for oncology therapeutics.
Domain
Oncology / Clinical Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical safety strategy, adverse event evaluation, risk management, regulatory reporting, signal detection, benefit-risk assessment, epidemiological data analysis, medical content development, cross-functional leadership
Preferred skills
UK Higher Medical Training in Pharmaceutical Medicine, MSc/PhD in scientific discipline, experience supervising patient safety colleagues
Technologies
Safety Knowledge Groups (SKG), Safety Informatics, modeling and simulation, PBRERs, PADERs, DSURs, NDA, BLA, MAA
Responsibilities
Define and implement clinical safety strategies; evaluate adverse events and safety data to predict/manage safety profiles; prepare regulatory reports (PBRERs, DSURs); lead safety governance and risk minimization activities; provide medical input for labeling and clinical trial documents; mentor team members on signal evaluation and risk management.
Seniority
Senior, hands-on IC with strategic leadership