Clinical Development Manager (US Clinical Study Lead)

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