Director, Drug Safety
Nurix•Brisbane, CA
•$247,300 - $317,100•Onsite
About The Position
Join Nurix’s pharmacovigilance team to help ensure patient safety across our clinical pipeline of targeted protein degradation therapies. As Director, Drug Safety, you’ll lead aggregate safety analysis, benefit–risk assessments, and safety strategy for assigned programs — shaping how we evaluate risk and bring new medicines safely to patients. It’s a chance to influence critical safety decisions at the intersection of clinical medicine, data, and drug development.
Requirements
- Advanced clinical or scientific degree, such as MD, DO, PharmD, or equivalent relevant training and experience
- Clinical experience preferred
- 5–10 years of experience in pharmacovigilance/drug safety within the pharmaceutical or biotechnology industry
- Experience supporting early clinical development and small biotechnology companies
- Demonstrated expertise in aggregate safety analysis and benefit–risk evaluation
- Strong knowledge of global pharmacovigilance regulations and guidance (ICH, FDA, EMA, MHRA)
- Experience interacting with global health authorities on safety matters
- Familiarity with signal detection and safety surveillance tools and databases
- Strong communication, collaboration, and cross-functional leadership skills
- Ability to interpret complex clinical and safety data and translate insights into regulatory and business strategy
- Ability to work effectively and collaboratively in a fast-paced, growing organization across functional boundaries
Responsibilities
- Serve as the medical safety lead for assigned products, providing clinical and pharmacovigilance expertise to safety strategy and activities
- Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization
- Conduct medical review and interpretation of safety data, contributing to benefit–risk assessments
- Monitor emerging safety signals and proactively address potential safety risks through appropriate internal and external communication
- Oversee medical review of Individual Case Safety Reports (ICSRs)
- Author and review regulatory safety documents, including Development Safety Update Reports (DSURs) and safety sections of INDs and regulatory briefing books
- Contribute to safety responses to regulatory authorities and participate in regulatory interactions
- Provide clinical leadership during inspections and audits related to safety and risk management
- Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures
- Collaborate with clinical development, regulatory affairs, medical affairs, and other stakeholders to ensure a consistent global safety strategy
- Serve on safety governance committees, supporting strategic decision-making for risk mitigation and benefit–risk evaluation
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What This Job Offers
Job Type
Full-time
Career Level
Director
