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Posted 16 hours ago
Medical Director, Drug Safety
Nurix TherapeuticsMedical Director, Drug Safety
Requirements
Medical degree (MD), 10+ years pharmacovigilance experience, Expertise in aggregate safety analysis, Knowledge of global PV regulations
Skills
PharmacovigilanceDrug SafetyClinical Development
About the role
Responsibilities
- Serve as the medical safety lead for assigned products, providing clinical and pharmacovigilance expertise
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization
- Conduct medical review and interpretation of safety data for benefit–risk assessments
- Monitor emerging safety signals and proactively address potential safety risks
- Author and review regulatory safety documents including DSURs, safety sections of INDs, and regulatory briefing books
- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures
- Collaborate with clinical development, regulatory affairs, and medical affairs to ensure a consistent global safety strategy
- Serve on safety governance committees to support strategic decision-making
Requirements
- Medical degree (MD)
- 10+ years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotechnology industry
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation
- Strong knowledge of global pharmacovigilance regulations (ICH, FDA, EMA, MHRA)
- Experience supporting early and late-stage clinical development and regulatory submissions
- Experience in post-marketing safety surveillance and risk management
- Experience interacting with global health authorities on safety matters
- Familiarity with signal detection and safety surveillance tools and databases
- Ability to interpret complex clinical and safety data
About the Company
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines aimed at improving treatment options for patients with cancer and inflammatory diseases.
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Get started — it's freeMedical Director, Drug Safety
Nurix Therapeutics · Brisbane
