Director Clinical Operations

About This Role

This Director of Clinical Operations leads and directs the execution of multiple clinical programs within a Therapeutic Area Unit (TAU), reporting to the Senior Director, Clinical Operations. The role involves line management, expert counsel for issue resolution, and providing Clinical Operations leadership. The assigned programs are typically large, complex, high-risk, or of significant business importance to Takeda, requiring multi-functional leadership skills.

Responsibilities

• Oversee Clinical Operations Program Leads (COPLs) assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or Clinical Sub Team (CST), working closely with GPT Leadership to ensure program objectives are met
• Represent Clinical Operations for assigned program(s) in issue escalation/awareness with senior management, such as functional or regional executive staff, PRC, and alliance governance committees
• Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy
• Account for program budget planning and external spend related to program execution, working closely with Global Program Management and Finance to ensure financial accuracy
• Ensure communication of program status, cost, and issues to inform timely decision-making by senior management
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned program(s), including escalation of issues to and participation in governance committees
• Account for operational risk management strategy in collaboration with Strategic Partners
• Account for inspection readiness and provide appropriate guidance to COPLs/COMs in support of inspection activities
• Collaborate with the Senior Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program(s)
• Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda’s values
• Represent and lead cross-functional initiatives as a recognized clinical operations expert
• Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence
• Assist in the role of Senior Director, Clinical Operations as required

Requirements

• Bachelor’s Degree or international equivalent required, Life Sciences preferred
• Advanced degree is highly desirable
• 12 or more years’ experience in pharmaceutical industry and/or clinical research organization
• 9+ years clinical study management experience
• Experience must include early phase experience or Phase 2 and 3 studies and global/international programs