Lead Clinical Study Manager

Role: Lead Clinical Study Manager responsible for designing, planning, and executing clinical studies within Takeda's development programs. Responsibilities include overseeing study operations, vendor management (CROs and strategic partners), ensuring compliance with ICH GCP, local regulations, and budget adherence. The role involves contributing to protocol development, site feasibility, study timelines, and risk mitigation, as well as managing external vendors and study budgets. Ensures studies are inspection-ready and supports regulatory inspections. Provides mentorship to junior staff and collaborates across functions. Requirements: BS/BA in life sciences or related field; 6+ years in pharma or CRO with at least 4+ years in clinical trial management, including global and/or early-phase or Phase 2/3 studies; knowledge of global regulatory standards (ICH GCP, CFR, EU CTD); excellent project management, communication, and collaboration skills. Preferred: experience across multiple therapeutic areas, advanced degrees, and international study oversight. HighValue: multi-indication clinical programs, global scope, CRO/vendor oversight, regulatory compliance, focus on clinical operations. Work setup: remote Massachusetts; travel 5-20% for site and partner visits.