4h ago

Senior Director, Toxicology

Cambridge, MA

$215k-$260k / year

full-timeleadbiotechnology

💼 About This Role

You'll lead toxicology strategy for a clinical-stage biotech pioneering precision allosteric therapeutics. You'll design and oversee nonclinical safety studies to support IND/CTA submissions, directly impacting drug development decisions.

🎯 What You'll Do

  • Serve as toxicology SME on program teams across all stages of drug development
  • Design, oversee, and interpret GLP/non-GLP toxicology and safety pharmacology studies at CROs
  • Author toxicology sections of regulatory documents (INDs, IBs, CTAs, briefing packages)
  • Represent company at regulatory agency meetings regarding non-clinical safety

📋 Requirements

  • PhD in Toxicology, Pharmacology, or related field (or DVM)
  • 10+ years experience in industry toxicology or pathology role
  • Direct experience developing toxicology strategy for small molecule clinical development
  • Experience with EMA and FDA CTA/IND submissions and regulatory interactions

✨ Nice to Have

  • Experience with reproductive/developmental toxicology and carcinogenicity studies
  • Track record of toxicology leadership on multiple programs at early and late stages

🎁 Benefits & Perks

  • 💼 Dynamic high-growth company with top-tier investors
  • 🔬 Opportunity to build Toxicology function from ground up
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