Lead Clinical Study Manager

Role: Lead Clinical Study Manager responsible for overseeing clinical trial strategy and execution within Takeda's clinical development programs. Primary objectives include ensuring studies are conducted in compliance with quality standards (ICH GCP, regulations), on schedule, and within budget. Responsibilities encompass study planning, operational oversight of high-complexity trials (possibly multi-indication or involving DSMBs), vendor management, and collaboration on protocol development, feasibility, and site selection. The role involves budget management, vendor negotiations, risk mitigation, and regulatory inspection readiness. It also includes mentoring junior staff and participating in functional initiatives. Qualifications: BS/BA in life sciences or related field; 6+ years' experience in pharma or CRO, including at least 4 years in clinical study management, with exposure to early phase or Phase 2/3/ global studies. Knowledge of global regulatory standards (US CFR, EU CTD, ICH GCP) required. Skills in project management, stakeholder communication, and team leadership essential. Preferred: advanced degrees, experience across multiple therapeutic areas, and international study oversight. The role is remote-based in Massachusetts with 5-20% travel, including international. Focus areas include clinical operations, vendor oversight, and compliance within a biologics or small molecule pipeline, supporting Takeda’s patient-centric R&D efforts.