Director, Clinical Systems — Remote Trial Delivery

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

Job summary

Takeda Pharmaceutical Co. seeks a Director, Clinical Systems to own the strategic direction for trial-delivery software such as EDC and data review tools.

You will partner with digital, data, and technology teams to shape roadmaps, lead implementations, and realize value from system investments. The role requires 10+ years in life sciences, deep regulatory knowledge (GxP, 21 CFR Part 11), and strong cross-functional leadership.

Qualifications

• Bachelor’s degree and 10+ years in life sciences or related roles.
• Hands-on experience implementing clinical systems for trial delivery (EDC, data review).
• Experience supporting regulatory inspections involving clinical systems (GCP).
• Deep understanding of 21 CFR Part 11 and system compliance.

Responsibilities

• Own clinical systems used in trial delivery and lead the SDLC.
• Shape and deliver system roadmaps with digital and data teams.
• Build cross-functional relationships to align on priorities and needs.
• Maintain inspection readiness for clinical systems during inspections.
• Support change management for system roadmaps and adoption.
• Lead budget planning and oversight for system development and operations.
• Define and track value realization across clinical systems.
• Monitor vendors and drive innovation in the clinical systems space.

Skills

Cross-functional collaboration

Budget management

Regulatory compliance

GxP inspection readiness

Stakeholder engagement

Communication skills

Strategic roadmap development

Leadership

Education

Bachelor’s degree

Tools

Electronic data capture (EDC)

Data review tools

Job description

Takeda Pharmaceutical Co. seeks a Director, Clinical Systems to own the strategic direction for trial-delivery software such as EDC and data review tools.

You will partner with digital, data, and technology teams to shape roadmaps, lead implementations, and realize value from system investments. The role requires 10+ years in life sciences, deep regulatory knowledge (GxP, 21 CFR Part 11), and strong cross-functional leadership.