Scientific Director, Toxicology Job at Neurocrine Biosciences, San Diego, CA

  • Neurocrine Biosciences
  • San Diego, CA

Job Description

Responsibilities

  • Lead toxicology program strategy and regulatory execution for nonclinical safety assessments
  • Evaluate due diligence programs and provide strategic direction for development path
  • Review regulatory submission documents including INDs, CTAs, NDA/MAA, and briefing books
  • Guide study designs, interpret safety pharmacology and toxicology data, and review study reports
  • Manage toxicology staff and collaborate across discovery, clinical, and regulatory functions

Requirements

  • DVM and/or PhD with specialty training in toxicology
  • 10+ years industry experience in biotech or pharmaceutical toxicology
  • Expert knowledge in nonclinical safety assessment across multiple drug modalities
  • Strong experience designing, overseeing, and interpreting GLP and non-GLP toxicology studies
  • Deep understanding of FDA, EMA, and global regulatory requirements for nonclinical safety
  • Demonstrated ability to lead internal teams, consultants, and CRO partnerships
  • DABT diplomate status preferred

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