Clinical Leader - Pharmaceutical Company

Location: Osaka, Japan
Job Type: 正社員
Salary ¥11000000.00 - ¥15000000.00 per annum
Specialization: ライフサイエンス・ヘルスケア・医療機器・製薬
Sub-specialization 臨床開発(プロジェクトマネージャー)
お問合せ Reid Aune
参照 JO-1909-425629
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  • Leads the Clinical Team, across functional team of internal experts, through clinical trials, global product registration. Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads.
  • Member of the JPT (Japan Project Team) representing Oncology-Clinical development and member of the Launch team, representing Oncology-CND
  • In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved CDP. Proactively initiates corrective action as needed.
  • Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
  • In consultation with the Head of the Oncology-CND and Global Clinical Leader/Global Development Lead, is responsible for communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities). Prepares assessments and recommendations, and presents them together with the Program Leader to the Japan Medical & Development Committee.
  • Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical leader/ Global Development Lead, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators' Brochures (IB).
  • Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the TA-MAF the publication strategy. Ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail.Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development.
  • Provides medical assessment of in- and out-licensing opportunities of development projects
  • Provides domestic study concepts to ensure compliance with global strategy
  • Coaches clinical leaders, clinical project managers and medical experts on their tasks and ensures aligned and consistent scientific/clinical contents across indications and products which target a similar disease area under the guidance of the Function Head.


  • 大学卒業以上 (MD or PHD)
  • 製薬医学及び薬剤開発での5年以上の経験があり、薬剤開発および上市までのプロセスを理解していること
  • グローバル企業における異文化が存在する中で、明確なビジョン、方向性や目的意識が持てること
  • 英語:上級レベル(上級の英語力(TOEIC730点以上)
  • 日本語:ネイティブレベル
  • PCスキル(ワード、エクセル、パワーポイントの基本操作)
  • プレゼンテーションおよびコミュニケーションスキル(日英)
  • 多国籍のチームおよびクロスファンクショナルチームで効果的に業務ができる


  • 医師免許をお持ちであれば尚可


  • 顧客との強固な関係を構築し、顧客の立場に立った解決策を提供できる。
  • 厳しい状況にあっても、説明責任を保ちながら、着実に成果に結びつけることができる。
  • 組織目標と整合した方策を推進するために、計画を立案し、業務に優先順位をつけることができる。
  • 将来の可能性を見極めたうえで、現状を打破する戦略を策定できる。



9時00分〜17時30分 (休憩時間:12時30分〜13時30分)