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Director, Clinical Operations, Oncology

Takeda
Remote
United States
$174,500 - $274,230 USD yearly
Clinical Research and Development

Role Summary

Director, Clinical Operations, Oncology based remotely reporting to the Executive Director, Clinical Operations, Oncology. Lead and direct the execution of multiple clinical programs within a Therapeutic Area Unit (TAU) with accountability for quality, budget, and timelines. Provide Clinical Operations leadership and oversee external partners to meet program objectives and regulatory requirements.

Responsibilities

  • Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU).
  • Provide line management and expert counsel for issue resolution across assigned programs.
  • Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations.
  • Accountable for overall execution of assigned clinical program(s) with focus on quality, budget, and timelines.
  • Oversee Strategic Partners and other vendors to meet organizational objectives and ensure compliance with ICH-GCP.
  • Manage large, complex, high-risk programs or a suite of programs requiring multi-functional leadership to achieve goals.

Qualifications

  • Bachelorโ€™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 across early phase, Phase 2 and 3 studies, and global/international programs. Oncology experience required.
  • Experience in more than one therapeutic area and in line management is advantageous.
  • Strong leadership, project/program management, and matrix leadership capabilities.
  • Expertise in global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP) with awareness of local country requirements.
  • Supervisory experience; excellent teamwork, organizational, interpersonal, and problem-solving skills.
  • Fluent business English (oral and written); ability to influence without authority.
  • Entrepreneurial and innovative; able to drive change and operate in ambiguity; promotes knowledge sharing.

Education

  • Bachelorโ€™s Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.