Director, Nonclinical Development - ADME/DMPK

Role: Lead strategic nonclinical ADME/DMPK development for small molecule and peptide therapeutics from discovery through late-stage clinical trials and registration. Responsibilities: develop and oversee integrated DMPK strategies supporting IND-enabling to Phase 3, drive cross-functional collaboration, lead PK/PD and modeling analyses (PBPK, MIDD), inform first-in-human dose selection, and contribute to regulatory submissions and health authority interactions. Serve as the scientific authority in nonclinical pharmacokinetics, metabolism, and drug-drug interaction assessments, providing expert guidance and translating complex data into strategic decisions. Requirements: PhD in Pharmacokinetics, Pharmacology, or related field; 10+ years in industry with proven experience in small molecule drug development, nonclinical DMPK, and modeling approaches; strong regulatory knowledge; excellent communication skills for internal and external engagement. Preferred: experience supporting Phase 2/3 and NDA submissions; expertise in peptide or novel modalities; advanced PBPK platform skills; global regulatory exposure; biotech startup experience. High-Value: expertise in ADME, DMPK, translational science, modeling (PK/PD, PBPK), regulatory strategy, and cross-functional leadership. Work setup: hybrid in Boston, Massachusetts; some travel expected.