[R&D] Japan Clinical Leader
On-siteTokyo, Tokyo, Japan
Job Summary
Lead clinical development for assigned projects in Japan by formulating and executing global and local development strategies in collaboration with the Global Clinical Leader and Japan Development Team. Evaluate candidates, establish effective plans, and secure regulatory approvals by managing relationships with key opinion leaders, academic societies, and government bodies. Prepare and review high-quality documents including study outlines, briefing documents, and CTD submissions, while overseeing risk management plans and clinical data reviews. Lead the Japan Development Team to ensure successful study execution, manage independent data monitoring committees, and continuously propose improvements to daily workflows.
Required Qualifications
- >3 years or more experience in clinical development
- thorough understanding of the processes associated with clinical and regulatory submissions
- skill to design and execute development strategies
- advanced medical and pharmaceutical knowledge
- knowledge on clinical study operations including guidelines and SOPs
- skill to think logically, innovatively, and flexibly
- writing skills
- Leadership skills
- Team building skills
- networking skills
- Negotiation skills
- consensus building skills
- Problem solving skills
- Project management skills
- Excellent writing and communication skills in both Japanese and English
- Presentation skills
- logical and scientific expertise to discuss with internal/external and Japanese/global stakeholders
Desired Qualifications
- Scientific background in education
- Sustained delivery and innovation within the discipline
- Sustained contribution to the pharmaceutical R&D process at the study level
- Proven ability to contribute to multiple projects
- Successful management of medium-sized teams consisted by multiple functions
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