You will lead the planning, execution, and management of U.S. clinical trials—primarily in the area of colorectal cancer screening—for the groundbreaking imaging diagnostic support software (SaMD).
In a fast-paced startup environment, you will work closely with internal and external stakeholders and take ownership across the full lifecycle of clinical studies, from study initiation and execution to data collection/analysis and preparation for FDA submission.
Main Responsibilities
Position (Tentative):
Clinical Development Manager (U.S. Clinical Study Lead)
- Develop clinical trial strategies and implementation plans for studies conducted in the U.S.
- Coordinate, negotiate, and manage progress with clinical trial sites (medical institutions, CROs, etc.)
- Prepare and review study documentation, including protocols, informed consent forms, and case report forms (CRFs)
- Monitor study operations to ensure quality, progress, and data integrity
- Collaborate with data analysis teams and Regulatory Affairs to prepare FDA submission materials
- Drive collaboration with overseas partner companies and key opinion leaders (KOLs)
- Share clinical trial results internally and support external presentations and publications
Ideal Candidate Profile
- Proactively identifies problems and takes initiative without being limited by organizational boundaries or job titles
- Approaches ambiguous challenges with a positive, solution-oriented mindset
- Acts as a team player who can engage and mobilize others while taking independent ownership
- Thrives in a dynamic startup environment and responds with speed, flexibility, and adaptability
Required Qualifications
- At least 3 years of hands-on experience in clinical trials
- Experience in oncology clinical trials or research projects (preferably colorectal cancer or cancer screening)
- Native level Japanese and strong English communication skills for documentation and meetings (TOEIC guideline: 800+)
- Basic understanding of GCP and relevant clinical trial regulations
- Strong communication skills to collaborate effectively with diverse stakeholders (physicians, CROs, engineers, etc.)
Preferred Qualifications (Not Required)
- Experience in clinical studies outside of drug trials
- Practical experience in clinical development or clinical research for medical devices
- Experience in AI- or imaging-based diagnostic support (CAD/CADe/CADx) clinical development or evaluation studies
- Experience with U.S. clinical trials or 510(k)/De Novo submission projects
- Experience working in a medical device startup or small, agile team
- Bachelor's, Master's, or Doctoral degree in a relevant field (medicine, pharmacy, engineering, etc.)
- Ability to balance hands-on operational work with project management while coordinating both internal and external stakeholders
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