Lead Clinical Study Manager

Lead Clinical Study Manager responsible for overseeing clinical trial strategy and execution within Takeda's clinical development programs. Primary objective s include ensuring studies are conducted in compliance with quality standards (ICH GCP, regulations), on schedule, and within budget.

• study planning,
• operational oversight of high-complexity trials (possibly multi-indication or involving DSMBs),
• vendor management,
• collaboration on protocol development, feasibility, and site selection.
• budget management,
• vendor negotiations,
• risk mitigation,
• regulatory inspection readiness.
• mentoring junior staff
• participating in functional initiatives.

• 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.

• 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.