Director, Clinical Operations — Remote Global Programs Lead

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director, Clinical Operations to lead and direct execution of multiple clinical programs within a TAU, reporting remotely to the Senior Director. The role emphasizes quality, budget and timelines with vendor oversight to meet ICH-GCP.

Requires 12+ years in pharma/CRO, 9+ years in clinical study management, global/international programs, leadership in matrix environments, and fluent business English. Travel up to 10%.

Qualifications

• 12+ years in pharmaceutical industry and/or CRO, including 9+ years in clinical study management.
• Experience in early phase or Phase 2/3 studies and global/international programs.
• Experience in more than one therapeutic area and in line management is advantageous.
• Leadership and project/program management excellence with innovative operations approaches.
• Global regulatory and compliance expertise (US CFR, EU CTD, ICH GCP).
• Awareness of local country requirements; supervisory experience.
• Fluent business English (oral and written); ability to influence without authority.

Responsibilities

• Lead and direct execution of multiple clinical programs within a TAU.
• Provide leadership and counsel for issue resolution across staff.
• Oversee program budgets and external spend with Global Program Management and Finance.
• Ensure program status communication to inform senior management decisions.
• Oversee selection and supervision of Strategic Partners/CRO/vendors.

Skills

Leadership

Program management

Cross-functional collaboration

English fluency

Influence without authority

Innovative mindset

Change management

Education

Bachelor's degree

Advanced degree

Job description

Takeda is seeking a Director, Clinical Operations to lead and direct execution of multiple clinical programs within a TAU, reporting remotely to the Senior Director. The role emphasizes quality, budget and timelines with vendor oversight to meet ICH-GCP.

Requires 12+ years in pharma/CRO, 9+ years in clinical study management, global/international programs, leadership in matrix environments, and fluent business English. Travel up to 10%.