Lead and direct execution of clinical studies for an assigned clinical program, supporting clinical strategy defined in Clinical Study Plan (CSP) in support of the Integrated Global Development Plan (IGDP).
In close collaboration with Clinical Operations Managers:
- Responsible for execution of studies in assigned clinical program in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- 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 may be high complexity or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one program may be assigned.
- Plan and manage the overall execution of the assigned clinical program to meet necessary quality, budget and timelines, including making or recommending operational strategies and/or decisions (with input from Associate Directors, Clinical Operations and Regions) in support of achieving clinical program objectives; Responsible for Early Engagement process with Strategic Partners
- Represent Clinical Operations globally as a member of the Global Development Team, working closely with GDT Leadership to ensure program objectives are met; May represent Clinical Operations for assigned program in issue escalation/awareness with senior management, e.g. regional executive staff, GMC, alliance governance committees
- Matrix leader of cross-functional global Clinical Program Team responsible for operational strategy for assigned clinical program; serves as main point of contact for regional, global or cross functional issues, including any CRO/ vendor performance issues and Clinical Program Team resource issues
- Responsible for program budget planning and accountable for external spend related to program execution. Works closely with Clinical Study Manager(s), Project Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates program status, cost and issues to ensure 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, including escalation of issues to governance committees when warranted; Responsible for operational risk management strategy in collaboration with Strategic Partners
- Provide program-level direction to clinical study manager(s) for the development of study management plans including enrollment models and , risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO/Strategic Partner; collaborates with Associate Director, Clinical Operations to ensure inspection readiness.
- Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), and updates to IND and NDA documents; Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate
- Collaborates with Associate Director, Clinical Operations to ensure adequate clinical operations resources are assigned to program
- Support functional strategic initiatives and processes managed by Clinical Services Group
- Act as a role model for Takeda s values
- Responsible for the operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling, in collaboration with Director, Clinical Operations
- May be asked to represent Takeda at internal and external meetings, including Investigator Meetings
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree is highly desirable.
- 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.
- Demonstrated excellence in project/program management and matrix leadership
- Excellent teamwork, organizational, interpersonal, and problem solving skills
- Fluent business English (oral and written)
- 8+ years experience in pharmaceutical industry and/or clinical research organization, including 5+ years clinical study management.
- Experience must include Phase 2 and 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area is required.
- Requires approximately 10-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
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