Director, Nonclinical Development

Role: Director of Nonclinical Development leading toxicology, DMPK, and ADME strategies for small molecule and peptide pipeline programs from IND-enabling to late clinical stages, including Phase 3 and NDA planning. Responsibilities: develop and execute integrated nonclinical plans; serve as scientific lead on cross-functional teams; assess data packages, identify gaps, and propose risk mitigation; oversee external CRO studies; author and review regulatory documents; support regulatory interactions and agency meetings; synthesize complex data for decision-making and regulatory filings; collaborate with Clinical, Regulatory, CMC, and Project teams; operate effectively in a startup environment. Requirements: PhD, DVM, or similar in Toxicology, Pharmacology or related field; 10+ years experience in nonclinical biopharma development; deep expertise in toxicology, with strong DMPK/ADME knowledge; proven track record supporting INDs, regulatory submissions, and working with CROs; excellent scientific writing and communication skills. Preferred: experience in Phase 3 and NDA submissions; exposure to global regulatory agencies (EMA, PMDA); prior startup environment experience. HighValue: small molecules, peptides; IND-enabling through late-stage development; regulatory interactions (FDA, EMA); GxP compliance; cross-functional collaboration; hybrid Boston-based role with some travel.