Director Clinical Operations

Goals

Lead and direct the execution of multiple clinical program(s) within a Therapeutic Area Unit (TAU). Responsible for line management and provides expert counsel for issue resolution, including programs assigned to other staff, when required.

Provide Clinical Operations leadership under the direction of the Senior Director, Clinical Operations: Accountable for the overall execution of the assigned clinical program(s) with focus on quality, budget and timelines. Accountable for the oversight of Strategic Partners and other vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives.

The assigned clinical program(s) will be large, complex, high risk and/or of business importance to Takeda or potentially a suite of programs, requiring multi-functional leadership experience and skills to achieve program goals.

Accountabilities

• Oversee COPLs assigned to represent Clinical Operations as members of the Global Program Team (GPT) and/or 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, e.g. functional or regional executive staff, PRC, alliance governance committees.
• Contribute to the Clinical Development Plan(s) and associated operational strategy, in support of the Asset Strategy.
• Accountable for program budget planning and external spend related to program execution and works closely with Global Program Management, and Finance to ensure financial accuracy.
• Ensures communication of program status, cost and issues to inform timely decision-making by senior management.
• Oversight of 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; accountable for operational risk management strategy in collaboration with Strategic Partners.
• Accountable for inspection readiness and provides appropriate guidance to COPLs/COMs in support of inspection activities.
• Collaborates with and is responsible to 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.
• Recognized as a clinical operations expert by other functions and ability to represent and lead cross functional initiatives.
• May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
• Able to assist in role of Senior Director, Clinical Operations as required.

Education and Experience

• 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, including 9+ years clinical study management.
• Experience must include early phase experience or Phase 2 and 3 studies and global/international programs.
• Experience in more than one therapeutic area and in line management is advantageous.
• Demonstrated excellence in leadership and project/program management, including innovative operations approaches to achieving program goals.
• 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.
• Supervisory experience.
• Demonstrated excellence in project/program management and matrix leadership.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Able to influence without authority.
• 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.
• Support a culture of continual improvement and innovation; promote knowledge sharing.

Travel Requirements

Requires up to 10% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.