Director, Clinical Management — Strategy & Operations
Otsuka America Pharmaceutical Inc.
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Benefits offered by this job
Job summary
Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs.
The role collaborates with Senior Director to plan, execute, and complete programs within regulatory and budget constraints, ensuring consistency of study materials and data integrity. The role will drive development of the Clinical Development Plan, manage budgets, and coordinate with ESPs and other stakeholders while leading teams to successful outcomes and
Qualifications
- Comprehensive knowledge of clinical operations and GCP/ICH regulations.
- Extensive experience with CROs, outsourcing, and SOW evaluation.
- Deep understanding of drug development and trial management.
- Strong regulatory knowledge and medical writing awareness.
Responsibilities
- Provide scientific clinical research and operational input for the Global Clinical Development Plan.
- Represent Clinical Management in timelines, budgets, and BD opportunities.
- Ensure standardization of CRFs, outsourcing specs, and training across studies.
- Contribute to clinical trial reports, publications, and presentations.
Skills
Education
Tools
Job description
Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs.
The role collaborates with Senior Director to plan, execute, and complete programs within regulatory and budget constraints, ensuring consistency of study materials and data integrity. The role will drive development of the Clinical Development Plan, manage budgets, and coordinate with ESPs and other stakeholders while leading teams to successful outcomes and
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