Remote Senior Clinical Operations Program Lead

Regulatory Jobs; Massachusetts; Remote; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Clinical Operations Program Lead for a remote role reporting to the Executive Director, Clinical Operations. The role drives program-level operational strategy, oversees vendor execution, and partners with global teams to ensure timely, high-quality clinical studies within budget.

Qualified candidates have 10+ years in pharma/ CRO, 7+ years in clinical project management, and strong leadership, communication, and regulatory expertise.

Qualifications

• Bachelor’s degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
• 10+ years’ experience in pharmaceutical industry and/or clinical research organization, including 7+ years clinical study/project management.
• Experience must include 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 but not limited to US CFR, EU CTD, and ICH GCP.
• Awareness of local country requirements is also required.
• Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning.
• Demonstrated excellent matrix leadership and communication skills.
• Able to influence without authority.
• Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo.
• Pragmatic and willing to drive and support change.
• Is comfortable with ambiguity.
• Embody a culture of continual improvement and innovation; promote knowledge sharing.
• Fluent business English (oral and written).

Responsibilities

• Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.
• Represent Clinical Operations at the Global Program Team and partner with Global Clinical Lead to lead the Clinical Sub Team accountable for the development and execution of the CDP.
• Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.

Skills

Matrix leadership

Communication

Teamwork

Problem-solving

Interpersonal skills

Conflict resolution

Change management

Influence without authority

Ambiguity tolerance

Initiative / proactiveness

Education

Bachelor’s degree in Life Sciences

Advanced degree desirable

Job description

Takeda is seeking an Associate Director, Clinical Operations Program Lead for a remote role reporting to the Executive Director, Clinical Operations. The role drives program-level operational strategy, oversees vendor execution, and partners with global teams to ensure timely, high-quality clinical studies within budget.

Qualified candidates have 10+ years in pharma/ CRO, 7+ years in clinical project management, and strong leadership, communication, and regulatory expertise.