Director, Clinical Pharmacology

Role: Lead clinical pharmacology activities supporting CNS programs within a biopharma setting, responsible for dose optimization, strategy design, and regulatory submissions. Responsibilities: design and execute PK/PD modeling, population pharmacokinetics, and simulation-based trial planning; contribute to regulatory interactions and documentation; promote model-informed drug development through collaborations and publications; actively participate in multidisciplinary teams. Requirements: Ph.D. or Pharm.D. in Pharmaceutical Sciences or related field; 10+ years of industry experience with proven leadership in clinical pharmacology; strong expertise in PK/PD modeling, bioanalytical analysis, and nonclinical ADME; experience with CNS therapeutics preferred. Knowledge of FDA guidance, regulatory submissions (IND/NDA), and programming skills (e.g., NONMEM, Phoenix NLME) highly desirable. High-value specifics: CNS therapeutics, small molecules, clinical development across all stages, regulatory engagement, and model-based drug development. Collaboration: cross-functional project teams and external stakeholders. Work setup: onsite 3 days/week in Waltham, MA; no travel specified.