Director, Clinical Systems: Trial Delivery & Compliance

Takeda; Boston (MA); Remote; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director of Clinical Systems to own and strategically direct clinical systems supporting trial delivery, including EDC and data review tools. This role partners across Global Development and enterprise teams to shape roadmaps, ensure inspection readiness, and maximize value from system investments.

You will work with digital, data, and technology partners to drive implementation, manage budgets, and promote efficient change management, delivering compliant, scalable systems

Qualifications

• Bachelor’s degree and 10 years of relevant experience in life sciences, drug development, trial delivery technology implementation, product management, or strategic roadmap definition.
• Hands-on experience implementing clinical systems for trial delivery, including electronic data capture or data review systems.
• Experience in Good Clinical Practice inspection settings, including supporting regulatory inspections involving clinical systems.
• Deep understanding of system compliance requirements, including regulated-system validation, 21 CFR Part 11 requirements, and requirements for blinded data.
• Demonstrated experience managing budgets, including financial planning and forecasting.

Responsibilities

• Own clinical systems used in trial delivery and provide business leadership throughout the software development lifecycle.
• Shape and deliver system roadmaps in partnership with digital, data, and technology teams and leadership.
• Build cross-functional relationships to understand business priorities, challenges, and clinical system needs.
• Maintain inspection readiness for clinical systems and provide system expertise during Good Clinical Practice inspections.
• Support change management for clinical systems and promote understanding and adoption of system roadmaps.
• Lead budget planning and oversight for clinical system development, operations, support, forecasting, and investments.
• Define and track value realization associated with investments across clinical systems.
• Monitor vendors and innovation to maintain awareness of the evolving clinical systems landscape.

Skills

Cross-functional collaboration

Budget planning

Communication skills

Problem-solving

Interpersonal skills

Education

Bachelor’s degree

Job description

Takeda is seeking a Director of Clinical Systems to own and strategically direct clinical systems supporting trial delivery, including EDC and data review tools. This role partners across Global Development and enterprise teams to shape roadmaps, ensure inspection readiness, and maximize value from system investments.

You will work with digital, data, and technology partners to drive implementation, manage budgets, and promote efficient change management, delivering compliant, scalable systems