Nurix

Director, Drug Safety

Brisbane, California. Posted a month ago

The role

You will lead aggregate safety analysis, benefit–risk assessments, and safety strategy for assigned programs. You will serve as the medical safety lead to ensure patient safety across the clinical pipeline of targeted protein degradation therapies.

What you will do

  • Serve as the medical safety lead for assigned products
  • Lead aggregate safety data analysis for signal detection, signal evaluation, and risk characterization
  • Conduct medical review and interpretation of safety data
  • Monitor emerging safety signals and address potential safety risks
  • Oversee medical review of Individual Case Safety Reports (ICSRs)
  • Author and review regulatory safety documents including DSURs and safety sections of INDs
  • Contribute to safety responses to regulatory authorities
  • Provide clinical leadership during inspections and audits
  • Provide clinical input into safety aspects of clinical trial protocols, informed consent forms, and investigator brochures
  • Serve on safety governance committees

Required qualifications

  • Advanced clinical or scientific degree, such as MD, DO, PharmD, or equivalent relevant training and experience
  • 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

Nice to have

  • Clinical experience preferred

About the company

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines. The company aims to establish degrader-based treatments at the forefront of patient care.

Director, Drug Safety at Nurix | JobZoey