Director, Clinical Systems — Remote Trial Leadership

Takeda Pharmaceutical Co.; Agawam (MA); Ibrido; USD 200.000 - 278.000; Tempo pieno

Descrizione del lavoro

Takeda Pharmaceutical Co. in Massachusetts (virtual) seeks a Director, Clinical Systems to lead the business ownership and strategic direction of trial delivery systems, including eClinical tools.

You will partner with digital, data, and enterprise teams to shape roadmaps and ensure inspection readiness. You will own budgets, drive value realization, and foster cross-functional collaboration to deliver compliant, scalable systems that support regulatory inspections and evolving clinical delivery

Competenze

• Bachelor's degree and 10 years of relevant experience in life sciences or drug development.
• Hands-on experience implementing clinical systems for trial delivery.
• Experience in Good Clinical Practice inspection settings.
• Understanding of 21 CFR Part 11 and regulated-system validation.
• Demonstrated budgeting experience.
• Cross-functional collaboration skills.
• Excellent written and verbal communication.

Mansioni

• 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.

Conoscenze

Clinical systems implementation

Regulatory compliance

Budget management

Cross-functional collaboration

Communication

Formazione

Bachelor's degree

Descrizione del lavoro

Takeda Pharmaceutical Co. in Massachusetts (virtual) seeks a Director, Clinical Systems to lead the business ownership and strategic direction of trial delivery systems, including eClinical tools.

You will partner with digital, data, and enterprise teams to shape roadmaps and ensure inspection readiness. You will own budgets, drive value realization, and foster cross-functional collaboration to deliver compliant, scalable systems that support regulatory inspections and evolving clinical delivery