Remote Senior Clinical Operations Program Lead

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Clinical Operations Program Lead (remote) reporting to the Executive Director, Clinical Operations. The role drives program-level operational strategy, vendor oversight, and cross-functional alignment across global teams from the Massachusetts/virtual base.

Must have 10+ years in pharma/ CRO, 7+ in PM, and strong regulatory knowledge, with fluent business English. Massachusetts Virtual location supports flexible work arrangements within the U.S. workforce.

Qualifications

• Bachelor’s degree or international equivalent required, Life Sciences preferred.
• 10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management.
• Experience in early phase clinical studies/Phase 2 studies or later phase global programs.
• Experience in more than one therapeutic area is highly desired.
• Expertise in global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP.
• Fluent business English (oral and written).

Responsibilities

• Develop and lead the program-level operational strategy and planning.
• Represent Clinical Operations at the Global Program Team (GPT) and lead the Clinical Sub Team (CST).
• Provide program-level sponsor’s operational oversight of partners and vendors.
• Budget planning and accountability for external spend on clinical program execution.
• Lead cross-functional initiatives for process and/or business improvements.
• Communicate program status to senior management.

Skills

Leadership

Program management

Budget management

Cross-functional collaboration

Regulatory knowledge

Communication

Education

Bachelor's degree in Life Sciences

Advanced degree desired

Job description

Takeda is seeking an Associate Director, Clinical Operations Program Lead (remote) reporting to the Executive Director, Clinical Operations. The role drives program-level operational strategy, vendor oversight, and cross-functional alignment across global teams from the Massachusetts/virtual base.

Must have 10+ years in pharma/ CRO, 7+ in PM, and strong regulatory knowledge, with fluent business English. Massachusetts Virtual location supports flexible work arrangements within the U.S. workforce.