Executive Director, Clinical Pharmacology

Role: Executive Director of Clinical Pharmacology providing strategic scientific leadership for PK, PD, and immunogenicity data interpretation across biologic development programs, from preclinical to late-stage. Responsibilities: guide dose selection, clinical trial design, and regulatory strategy by analyzing PK and ADA data from animal models and humans; serve as subject-matter expert on clinical teams; author and review regulatory documents; support assay design and immunogenicity impact assessment. Requirements: PhD in Pharmacology, Pharmaceutical Sciences, or related; 12+ years in biologic drug development with proven program leadership; expertise in clinical/non-clinical PK, ADA, exposure-response, and translational PK principles; experience supporting INDs and regulatory interactions; strong scientific communication skills. HighValue: biologics, cardiovascular applications, immunogenicity, PK/PD modeling, regulatory submissions, IND-enabling to late-stage clinical phases. WorkSetup: onsite in Lexington, MA.