Remote Oncology Clinical Ops Associate Director, Program Lead

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

Job summary

Takeda seeks an Associate Director, Clinical Operations Program Lead, Oncology to oversee program-level operational strategy for oncology studies. This remote role reports to the Executive Director and requires global collaboration with partners and vendors to deliver on-time, high-quality studies within budget.

The candidate will lead cross-functional teams, ensure regulatory compliance, and drive continuous improvement in clinical operations across multiple therapeutic areas.

Qualifications

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

Responsibilities

• Translate CDP into an optimal operational strategy and plan.
• Lead the clinical program operational strategy with COMs, CROs, and vendors.
• Oversee budgets and external spend related to clinical program execution.
• Collaborate with cross-functional teams to ensure timely, high-quality studies.
• Prepare regulatory documents and participate in key regulatory meetings as appropriate.
• Demonstrate leadership, adapt to changing environments, and drive process improvements.

Education

Bachelor’s Degree or international equivalent

Advanced degree

Job description

Takeda seeks an Associate Director, Clinical Operations Program Lead, Oncology to oversee program-level operational strategy for oncology studies. This remote role reports to the Executive Director and requires global collaboration with partners and vendors to deliver on-time, high-quality studies within budget.

The candidate will lead cross-functional teams, ensure regulatory compliance, and drive continuous improvement in clinical operations across multiple therapeutic areas.