Remote Director of Clinical Operations – Programs

Regulatory Jobs; Massachusetts; Remote; USD 177,000 - 278,000; Full time

Job summary

Takeda seeks a Director, Clinical Operations to lead multiple clinical programs within a Therapeutic Area Unit, reporting to the Senior Director, Clinical Operations. This remote-friendly role focuses on execution, budget oversight, and CRO/vendor management across global programs.

The position requires 12+ years in pharma/CRO, strong leadership, and extensive regulatory knowledge; international study experience is essential. Up to 10% travel may be required.

Qualifications

• Bachelor’s degree in Life Sciences or related field; advanced degree preferred.
• 12+ years in pharma/ CRO with 9+ years of clinical study management.
• Experience in global regulatory/compliance requirements (US CFR, EU CTD, ICH GCP).

Responsibilities

• Lead and direct execution of multiple clinical programs within a TAU.
• Oversee COPLs, CSTs, and interactions with GPT Leadership and senior management.
• Accountable for program budget, external spend, and vendor performance.
• Ensure inspection readiness and regulatory compliance across studies.
• Collaborate with Senior Director to allocate resources and drive innovation.

Skills

Leadership

Program management

Budget management

Vendor management

Global/regulatory knowledge

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree or international equivalent

Advanced degree (highly desirable)

Job description

Takeda seeks a Director, Clinical Operations to lead multiple clinical programs within a Therapeutic Area Unit, reporting to the Senior Director, Clinical Operations. This remote-friendly role focuses on execution, budget oversight, and CRO/vendor management across global programs.

The position requires 12+ years in pharma/CRO, strong leadership, and extensive regulatory knowledge; international study experience is essential. Up to 10% travel may be required.