Remote Associate Director, Clinical Operations - Oncology

Takeda

5 days ago

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Bachelor’s Degree or international equivalent; Life Sciences preferred.
10+ years in pharmaceutical industry and/or clinical research organizations.
7+ years clinical study/project management experience.
Experience in early phase and Phase 2 or later global programs.
Expertise in global regulatory and compliance for clinical research (US CFR, EU CTD, ICH GCP).
Excellent matrix leadership, communication, and problem-solving skills.
Fluent business English (oral and written).

Develop and lead the program-level operational strategy for assigned oncology programs with partners and vendors.
Represent Clinical Operations at GPT and collaborate with Global Clinical Lead on CDP development and execution.
Oversee budget planning and external spend for clinical program execution with COMs, GPM, and Finance.
Escalate and resolve issues at study level; oversee performance of CROs and vendors.
Lead or participate in cross-functional strategic initiatives and process improvements.
Ensure regulatory readiness and provide input into regulatory submissions and key meetings.