Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Role: Associate Director, Quantitative Clinical Pharmacology Lead at Takeda, based in Cambridge, MA. Responsibilities include leading strategic and scientific aspects of multiple drug development projects, from first-in-human to lifecycle management, with a focus on dose selection and causality evidence. The role involves integrating PK, PD, efficacy, and safety data, developing and executing clinical pharmacology plans aligned with Model-Informed Drug Development (MIDD) principles, and supporting regulatory interactions through the preparation of clinical pharmacology documents. The position requires oversight of PK/PD and pharmacometric analyses, mentorship of junior staff, and active participation in scientific dissemination and industry collaborations. Requirements: PharmD or PhD with 5+ years (PharmD) or MS with 8+ years in quantitative fields involving clinical pharmacology/PK-PD. Advanced expertise in early and late-stage clinical pharmacology, familiarity with regulatory guidance (ICH, FDA, EMA), and experience in cross-functional collaboration with biostatistics, digital health, and other disciplines are essential. The role emphasizes leadership in strategic decision-making, scientific communication, and industry best practices. High-value specifics include focus on innovative biopharma development, digital integration, and model-informed approaches within global clinical programs. The position is hybrid, with potential for scientific influence beyond internal teams, and offers a competitive salary range of $154,400–$242,550, plus comprehensive benefits.