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Medical Director, Safety Physician - Oncology

US - Gaithersburg - MD💼 Full-time💰 $249,827–$249,827🗓 2026-07-06 → 2026-07-31

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

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