Remote Associate Director, Clinical Operations Program Lead

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking an Associate Director, Clinical Operations Program Lead for a remote position reporting to the Executive Director.

The role oversees global clinical program operations, partners with CROs and vendors, and guides the CDP development and execution. The position requires 10+ years in pharma/ CRO settings, strong program management, strategic planning, budgeting, and regulatory expertise, with fluent business English and cross-functional leadership across

Qualifications

• Bachelor’s degree in Life Sciences or international equivalent.
• 10+ years in pharmaceutical industry or CRO with 7+ years in clinical study/project management.
• Experience in early phase studies/Phase 2 or later global programs.
• Expertise in global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP).

Responsibilities

• Develop and lead the program-level operational strategy and planning for assigned programs.
• Represent Clinical Operations at the Global Program Team and lead the Clinical Sub Team for CDP development and execution.
• Oversee budget planning and external spend related to clinical program execution.
• Act as escalation point for the COMs; supervise performance of CROs and vendors.
• Support regulatory readiness and inspection activities as appropriate.

Skills

Program management

Cross-functional leadership

Regulatory knowledge

Budget management

Strategic planning

Communication

Education

Bachelor’s degree or international equivalent, Life Sciences preferred

Advanced degree desirable

Tools

CRO oversight

Budget forecasting

Job description

Takeda Pharmaceutical Co. is seeking an Associate Director, Clinical Operations Program Lead for a remote position reporting to the Executive Director.

The role oversees global clinical program operations, partners with CROs and vendors, and guides the CDP development and execution. The position requires 10+ years in pharma/ CRO settings, strong program management, strategic planning, budgeting, and regulatory expertise, with fluent business English and cross-functional leadership across