臨床科学リーダー/ Clinical Science Lead

A renowned biotechnology company is seeking a Clinical Science Lead / Program Lead. The successful candidate will oversee protocol development, clinical operations, and documentation to support IND submission and trial readiness.

Responsibilities:

• Refine clinical trial protocols and inclusion/exclusion criteria in collaboration with medical advisors and KOLs
• Identify and build relationships with clinical sites and investigators to support trial initiation
• Evaluate, select, and manage CRO partners to ensure quality and compliance in trial execution
• Lead preparation of key regulatory documents including IB, protocol, and informed consent forms for IND submission
• Oversee grant-related documentation and reporting for AMED clinical development programs
• Participate in meetings for U.S. clinical trials, address operational issues, and liaise directly with U.S.-based stakeholders

Requirements:

• Experience in Clinical Science or Clinical Development at a pharmaceutical company or CRO
• Prior experience in hematology, oncology, or regenerative medicine
• Proven experience in global clinical trials
• Skilled in protocol design, trial execution, and regulatory submissions
• Proficient in English and Japanese

About the Company:

A pioneering biotechnology company specialising in regenerative medicine and cell-based therapies. The organisation is dedicated to developing innovative treatments that harness the power of cells to restore health and improve patients’ quality of life.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: Q8C6H4