Nurix

Senior Director, Nonclinical Toxicology

Brisbane, California. Posted 9 days ago

The role

Lead toxicology strategy across discovery, preclinical and clinical development. You will guide exploratory and GLP safety studies and assess human risk of novel therapeutic targets.

What you will do

  • Design and management of exploratory and GLP toxicology and safety pharmacology studies
  • Lead toxicology strategy and tactics in discovery, preclinical development and clinical development
  • Participate in multi-disciplinary team efforts and implement program-specific toxicology strategies
  • Monitor outsourced GLP and non-GLP studies
  • Write and review toxicology protocols, reports, and documentation for regulatory filings
  • Apply understanding of toxicology, pharmacology, ADME, and regulatory guidelines to study design
  • Provide creative approaches to expedite nonclinical development strategies
  • Provide a critical review of toxicology study protocols, data and study reports
  • Serve as the Toxicology representative on multi-functional project teams
  • Contribute to the preparation of high-quality regulatory documents

Required qualifications

  • Ph.D. in Toxicology, Pharmacology, or a related field with a minimum of 10 years, or M.S. degree with a minimum of 15 years, of pharmaceutical or biotechnology industry experience as part of a drug de
  • Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
  • Experience in writing and reviewing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
  • Extensive drug development experience with strong decision making and problem-solving skills
  • Excellent written and verbal communication skills
  • Experience in health-authority interactions and developing regulatory strategies
  • Competency in incorporating the use of NAMs in toxicological evaluations

Nice to have

  • Extensive experience in discovery and development of small molecules, degraders, and antibody drug conjugates is desirable
  • Board certification in toxicology is highly desired

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 uses an AI-integrated discovery engine to target protein classes for cancer and inflammatory diseases.

Senior Director, Nonclinical Toxicology at Nurix | JobZoey