Director of Toxicology

Location: This position may be performed remotely, but requires flexibility and willingness to travel as needed.

Primary Responsibilities
- Own nonclinical safety strategy for assigned programs to support candidate selection, IND-enabling development, clinical progression, and later-stage regulatory milestones.
- Design and oversee discovery, exploratory, investigative, and regulatory toxicology studies (non-GLP and GLP) from protocol development through interpretation and final reporting.
- Evaluate emerging safety findings; assess relevance to human risk and recommend pragmatic paths forward.
- Lead regulatory toxicology activities (INDs, CTAs, IBs, DSURs, NDA/MAA-related documents, and responses to FDA/other global authorities).
- Direct CROs/consultants/external partners for scientific quality, compliance, timelines, and communication.
- Partner cross-functionally to integrate nonclinical safety into program strategy and decisions.

Qualifications and Key Success Factors
- Master’s or PhD preferred in Toxicology, Pharmacology, Pharmacy, Biology, or related field; DABT desirable.
- 8+ years of relevant biotech/pharma/CRO/regulatory experience with meaningful nonclinical safety leadership and toxicology study direction/monitoring.
- Deep expertise in general toxicology; highly desirable: reproductive, genetic, safety pharmacology, carcinogenicity, and/or abuse potential assessment.
- Strong regulatory toxicology knowledge (ICH, FDA, OECD, U.S./international guidance); FDA Pharmacology/Toxicology reviewer experience valued.
- In-depth GLP knowledge; demonstrated oversight of GLP studies by external partners.
- Experience leading/developing toxicology talent and coaching.

Benefits/Compensation
- Annualized base salary: $220,000–$240,000 USD.