Senior Director, Drug Product CMC

Role: Senior Director of Drug Product within CMC, responsible for leading nonclinical and clinical formulation development of small molecule drug candidates, supporting Phase I-III programs. Responsibilities: manage external vendors (CROs, CDMOs), oversee physiochemical characterization, pre-formulation, and formulation work for oral, subcutaneous, and intravenous routes; author and review development protocols, coordinate supply shipments, and contribute to regulatory submissions. Requirements: Ph.D. in Chemistry, Pharmaceutical Sciences, or related field; 10+ years in drug formulation development, with expertise in poorly soluble small molecules and orally/parenterally delivered dosage forms; strong knowledge of analytical techniques (HPLC, XRPD, DSC, etc.), cGMP, and managing external partners. Preferred: experience with early-stage clinical programs, strategic leadership, and cross-functional collaboration in pharmaceutical sciences. High-Value: small molecule, nonclinical/clinical formulation, Phase I-III, cGMP compliance, vendor oversight, global travel. WorkSetup: US-based, occasional domestic/international travel.