Director, Clinical Operations, Oncology

Role Summary

Director, Clinical Operations, Oncology – remote (Massachusetts - Virtual), reporting to the Executive Director, Clinical Operations, Oncology. Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Provide Clinical Operations leadership and ensure the overall execution of assigned clinical programs with focus on quality, budget, and timelines. Oversee strategic partners and vendors to meet Takeda’s objectives and ensure program readiness and compliance.

Responsibilities

• Lead and direct the execution of multiple clinical programs within a TAU.
• Provide line management and expert counsel for issue resolution across programs as needed.
• Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
• Accountable for the overall execution of assigned programs with focus on quality, budget, and timelines.
• Oversee Strategic Partners and other vendors to meet obligations described in ICH-GCP and Takeda’s objectives.
• Manage large, complex, high-risk programs or a suite of programs requiring multi-functional leadership; support CSTs as needed.

Qualifications

• Bachelor’s Degree or international equivalent; Life Sciences preferred. Advanced degree highly desirable.
• 12+ years in the pharmaceutical industry, including 9+ years in clinical study management.
• Experience in early phase and/or Phase 2/3 studies and global/international programs; oncology experience required.
• Experience in more than one therapeutic area and line management is advantageous.
• Excellence in leadership and project/program management with innovative operations approaches.
• Expertise in global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP); awareness of local country requirements.
• Supervisory experience; strong teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written); ability to influence without authority.
• Entrepreneurial, innovative; willing to drive change and comfortable with ambiguity; supports knowledge sharing.

Education

• Bachelor’s Degree or international equivalent; Life Sciences preferred. Advanced degree desired.