【神奈川／東京】臨床開発スペシャリスト

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Job details

Company overview

We are engaged in research and development for regenerative medicine. We promote the social implementation of cell therapy products and iPS cell-related technologies, developing regenerative medicine products through cell transplantation, supporting drug discovery research, and establishing regenerative medicine research infrastructure. As a research and development-focused company, we specialize in the commercialization of regenerative medicine derived from iPS cells, grounded in scientific and technological foundations. Additionally, we utilize our knowledge of iPS cells to support drug discovery research and establish regenerative medicine infrastructure, while also promoting social activities to integrate iPS cells into communities and society. With a well-established technical foundation and a team of leading scientists and skilled technicians, we maintain a young and dynamic culture, sharing a commitment to leveraging Japan's iPS cell technology for the benefit of society. By delivering regenerative medicine to patients, we contribute to clinical settings and the broader community.

Responsibilities

臨床開発スペシャリストとして、臨床開発相の計画および実行業務を実施いただきます。

• 臨床開発戦略含む事業開発計画の策定支援
• 規制当局との面談等準備支援および参加
• 治験実施計画書の策定および実施
• 治験実施施設の選定、契約および GCP に基づく被験者モニタリング
• 治験実施に係る外注業務の選定、契約、および管理
• 治験報告書の策定
• 臨床施設における、臨床研究（治験もしくは医師主導試験）の実施支援

Requirements

• 医薬品、医療機器、再生医療品のいずれかに関する臨床開発業務の経験5年以上

Salary

6.2 - 11 million yen

Location

Tokyo