Clinical Scientist (4556)

＊This role requires native level Japanese and Business English＊

＊日本語がネイティブレベルで英語が流暢に会話ができる方(両方必須)＊

During the course of a clinical study, CDS is responsible for:

CDSは治験期間中、以下を実施する：

• The oversight of the clinical studies, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. In collaboration with the SM&M team, CDS is responsible for the oversight of overall timelines for key deliverables, including the management and submission of the Clinical Trial Notification (CTN).

• 治験中に得られた有効性及び安全性に関わる情報を確認、考察、伝達し、治験を監督する。SM&Mと協働し、治験の全体的なタイムラインを監督する（治験届の管理及び提出を含む）。

• Taking part in the study safety monitoring, in collaboration with TAMD/SD, PST leads and safety management group.

• TAMD/SD, PST Lead, 安全性部門と協働し、治験の安全性モニタリングに参加する。

• Preparing core clinical documents, including the Clinical Study Report.

• 治験に関する主要な文書(治験総括報告書を含む)を作成する。

• CDS prepares the clinical part of CTD and deal with the associated inquiries from the regulatory authorities.

• CDSはCTDの臨床パートを作成し、関連する規制当局からの照会事項に対応する。

• CDS is responsible for the development of the core contents of publications including presentations at academic conferences and manuscripts.

• CDSはパブリケーション（学会等の発表資料・論文作成等を含む）の主要な内容の責任者としてその作成又は確認を行う。

• CDS acts as the clinical interface and actively solicits key opinion leader (KOL) interactions; partners with JPT members including JPTL, Medical Affairs, Commercial and other functions in these activities as required, to ensure that broad cross-funcitonal perspectives are incorporated into the development, management and execution of the clinical development strategy.

• CDSは、社外の医学専門家(KOL)より臨床開発戦略上必要な見解を得るための窓口となる。また、CDSは臨床開発戦略の立案・管理・実行に関連部署それぞれの観点を適切に取り入れるべく、JPTL, 医学統括部，コマーシャル部等を含むJPTメンバーと連携する

経験／職歴 / Background/Experience:

• At least, 5 years experience in clinical development or equivalent knowledge of clinical development.

• 臨床開発経験が5年以上、もしくはそれに相当する臨床開発知識

学歴 / Education:

• Graduate from College of Nursing, College of Pharmacy, College of Science/Agriculture, or life-science course (Holder of master degree is preferable), or equivalent education

• 医学部、薬学部、看護学部、理学/農学部、もしくは生命科学系の大学学部卒かそれ以上

Job benefits 

• Work from home opportunities
• Common global interaction and same time launch dates as the global headquarters for top drugs
• Wage from 9,000,000 to 14,000,000 JPY depending on level