Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry. They are seeking a Director of Clinical Operations in Oncology to lead and direct multiple clinical programs, ensuring quality, budget adherence, and timely execution.

Responsibilities

• 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. If a single program is assigned, the program will typically be significant in scope (e.g., multiple independent indications with individual Clinical Sub Teams (CSTs))
• 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

Skills

• Bachelor's Degree or international equivalent required
• 12 or more years' experience in pharmaceutical industry, including 9 or more years in clinical study management
• Experience must include early phase experience or Phase 2 and 3 studies and global/international programs
• Oncology experience is required
• 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
• Life Sciences preferred
• Advanced degree is highly desirable
• Experience in more than one therapeutic area and in line management is advantageous

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• Up to 120 hours of paid vacation

Company Overview

Company H1B Sponsorship