Director, Clinical Systems

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

Job Description

About the Role

The Director, Clinical Systems provides business ownership and strategic direction for clinical systems that support trial delivery, including electronic data capture and data review tools. This role is part of Clinical Data Strategy & Operations within Global Development and partners across research and development and enterprise teams to ensure clinical systems address business priorities and operational needs. The Director works closely with digital, data, and technology partners to shape system roadmaps, support successful implementation, and realize value from system investments. Serving as the business owner and subject matter expert for clinical systems, this role helps ensure systems are inspection-ready, compliant with applicable requirements, and supported by effective processes and infrastructure. The role also contributes to change management and evolving ways of working for clinical system delivery.

How You Will Contribute

• 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.

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.
• Proven cross-functional collaboration skills within a matrixed organizational environment.
• Excellent written and verbal communication skills, with the ability to influence across functions and organizational levels.
• Strong interpersonal and problem-solving skills with demonstrated ability to build effective working relationships.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location

Massachusetts - Virtual

U.S. Base Salary Range

$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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