- Responsible for clinical operations strategy, execution and management of TDC global clinical programs in assigned therapeutic area or disease pathway or therapeutic area(s) or disease pathway(s), supporting clinical strategy defined in the Clinical Development Plan (CDP)
- Responsible for Global Clinical Operations financial planning/forecasting and budget management for assigned therapeutic area or therapeutic areas. Responsible for administrative budget oversight for direct and indirect reports.
- Represents Global Clinical Operations at therapeutic area or disease pathway level as primary point of contact for therapeutic area or disease pathway Heads, internal stakeholders and Strategic Partners and vendors
- Responsible for functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) in a matrix environment.
- Responsible for leading the development of consistent Clinical Operations processes and creating the support for unified approaches across Disease Pathways /Therapeutic Areas
- Initiates, Develops, Leads and/or Participates in global (cross-regional) initiatives representing Clinical Operations in support of both Global Clinical Operations and Takeda R&D cross functional drug develop objectives.
- On an as needed basis, develops project planning and leadership experience on selected cross functional Takeda initiatives by assisting or serving as deputy for Region Head, Clinical Operations, or the Global Head of Clinical Operations.
- Collaborates with Regional Heads of Development Operations to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of clinical trials in support of IGDP and studies in assigned TA or TAs.
- Ensures clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Direct management of Clinical Program Managers and Associate Directors, Study Management (who manage clinical study managers).
- Provides central point of contact for global clinical operations to PDD Therapeutic Area Heads, Strategic Project Management, Therapeutic Areas Leads, CMSO Global Project Leaders and Finance for strategy, planning, issue management, and program execution information.
- Responsible for global budget planning/forecasting and management for assigned therapeutic area or disease pathway.
- Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling
- Maintains current therapeutic area knowledge and continually assesses impact of new and evolving information on operational strategies
- Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues. Represents Development Operations (including Global Development Strategic Outsourcing) in senior PDD management forums.
- Supports Global Development Strategic Outsourcing by leading portfolio level planning and Early Engagement process with strategic vendors in assigned therapeutic area or therapeutic areas, making recommendations for program/study allocation with strategic vendors, and participation in strategic vendor governance, including identification and resolution of performance issues.
- Leads and/or Participates in Global Clinical Operations, Development Operations or TDC initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives.
- Responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment.
- Acts as a role model for Takeda s values
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
- At least 12 years clinical study/program management experience in the pharmaceutical industry, including at least 6 years of line management experience. Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level required.
Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
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