Director, Quantitative Clinical Pharmacology (QCP) Lead

Role: Director, Quantitative Clinical Pharmacology at Takeda, leading the clinical pharmacology strategy for global drug development programs from pre-FIH through lifecycle management. Responsibilities: oversee PK, PD, and modeling analyses; develop and execute clinical pharmacology plans; drive Model-Informed Drug Development (MIDD) practices; collaborate with cross-functional teams including pharmacometrics, statistics, and DMPK; represent pharmacology in regulatory interactions and prepare submission documents; mentor junior staff; and promote scientific leadership through industry participation. Qualifications: PhD or PharmD with 8+ years (or MS with 12+ years) experience in quantitative fields, with expertise in clinical pharmacology, PK/PD, and MIDD; proven record in regulatory submissions (NDA/CTD); strong knowledge of drug development processes across therapeutic areas. HighValue: focus on innovative, data-driven approaches in early to late-stage development, with global regulatory engagement and cross-disciplinary collaboration. WorkSetup: hybrid in Boston, MA; competitive salary range $177K–$278K, with benefits and incentives.