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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