Director, Nonclinical Development - Toxicology

Role: Director of Nonclinical Development, Toxicology, providing strategic leadership and execution of nonclinical safety programs for small molecules and peptides across early to late-stage development. Responsibilities: oversee integrated safety strategies from IND-enabling studies through Phase 2/3 and regulatory submissions; serve as toxicology expert on cross-functional teams; design and interpret GLP and non-GLP toxicology studies (including safety pharmacology, reproductive, juvenile, and carcinogenicity); lead external CROs; contribute to regulatory documents and agency interactions; and ensure alignment with global regulatory standards. Requirements: PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field; 10+ years in industry with significant toxicology leadership; experience advancing small molecule candidates from discovery through clinical stages; deep expertise in toxicology, safety pharmacology, DMPK principles, and ICH regulations; proven ability to influence cross-functional teams and manage CRO relationships; strong written/verbal communication skills. Preferred: experience supporting Phase 2/3 programs, NDA submissions, peptide therapeutics, juvenile toxicology models, and global regulatory interactions; exposure to early-stage biotech environments. High-Value: small molecule and peptide therapeutics, IND-enabling to late-stage development, regulatory interactions with agencies such as FDA and EMA, and work in a hybrid Boston-based setting with some travel.