Director, Clinical Pharmacology

Role: Director, Clinical Pharmacology at Takeda focuses on leading clinical pharmacology strategies for plasma-derived therapies targeting rare and complex diseases. Responsibilities include designing and overseeing clinical pharmacology programs to support drug development, registration, and commercialization; representing clinical pharmacology on project teams; leading study design, execution, and reporting; and contributing to regulatory submissions and interactions. The role entails managing pharmacometric projects such as PK/PD analyses, supporting dose optimization, pediatric development, and exposure-response assessments. It involves close cross-functional collaboration across R&D, regulatory, and external vendors, with a focus on plasma-derived products. Qualifications: Ph.D., Pharm.D., MD, or equivalent with at least 10 years in clinical pharmacology within the pharma industry; deep expertise in pharmacometrics, PK/PD, GxP, and regulatory processes; extensive experience in early and late-stage drug development, particularly plasma-derived therapies; strong strategic thinking, communication, and leadership skills. High-value: plasma-derived therapies, rare diseases, clinical pharmacology, pharmacometrics, PK/PD modeling, regulatory submissions, global project leadership. Work setup: hybrid in Cambridge, MA with no travel specified.