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Associate Director, Quantitative Clinical Pharmacology, Data and Quantitative Sciences

年収：1200万～ 1600万

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部署・役職名	Associate Director, Quantitative Clinical Pharmacology, Data and Quantitative Sciences
職種	臨床開発統計解析・SASプログラマー
業種	医薬品メーカー
勤務地	大阪府
仕事内容	You will formulate and execute strategies for efficient operation of clinical pharmacology from a cross-project perspective, collaborating with relevant divisions in and outside Japan, the project team, and the Global Function to enable seamless collaboration among the Project Team, partner CRO, and Global Members. Additionally, as an expert, you will contribute to solving cross-project problems within the Project Team, specifically related to QCP work. This role ensures Japan’s clinical pharmacology (CP) needs are aligned with the global clinical development plan through collaboration with Global QCP leads. It provides guidance to Japan’s local team for effective CP support across global and regional projects. Additionally, it assists the global head of QCP with technical, operational, and leadership contributions to uphold CP’s value and reputation. The role also leverages broad expertise in drug development to collaboratively support cross-functional initiatives that represent company objectives. 【ACCOUNTABILITIES】 Demonstrate an excellent knowledge of CP relevant Japan regulatory guidelines. Ensures that such expertise is homed within the CP regions and as such ensures CP expertise is available to provide clin pharm scientific and strategic leadership in reviews of such documents when requested. Expected to review and approve key submission documents (i.e. summaries of biopharma and clin pharm within the CTD and CTNs) when generated from their region. Review and approve responses to time-critical queries from health authorities and position statements on key clinical development aspects like rationale for the proposed dose. Leverage his/her broad development expertise across all stages of drug development and TAUs and MPD, to be a collaborative and informed expert in their field within the company. And considered within Takeda R&D a subject matter expert/ technical advisor in the area of CP while keeping abreast of emerging scientific/ regulatory advances and contribute to development of internal best practices. Be engaged with project members/junior staff to make major assessments that drive decisions around asset value, risks and probability of technical and regulatory success to inform business decisions around strategic investments. Provide appropriate guidance to ensure appropriate CP support and input is provided to global and local development projects that are supported by the department and ensures CP resources at outsourced vendors assigned to support local/global development programs if needed. Assists the global head of QCP by contributing to the technical and operational aspects of the CP within the company and by leading local CP initiatives as required, to ensure CP’s continued value and reputation within and outside the company. Seek opportunities to engage professional societies and external clin pharm and drug development bodies to guide and influence the messaging on CP in drug development. And through meetings and publications develop as the external face of Takeda Quantitative Clinical Pharmacology. Supported to allow their maximum contribution to development teams through the application of their drug development expertise and quantitative PK/PD approaches. For projects that may occasionally be asked to support: ensure high quality relevant documentation are prepared.
労働条件
応募資格	【必須（MUST）】・PhD, MS or equivalent required in a health-related, life science area, preferably in Pharmacology, Pharmacokinetics or Pharmacometrics associated. ・Pharm D. or PhD with 5+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD ・MS with 8+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD ・Extensive and broad experience with all phases of development especially in Japan development and multiple therapeutic areas, and an ability to handle multiple development programs simultaneously. ・Experience of working with Japanese agencies, PMDA/MHLW, and hopefully other international regulatory agencies, such as MHRA, FDA, and EMEA. ・Good knowledge on Pharmacometrics, especially on population PK and E-R analysis and experience of at least one PK related software (Winnonlin, NONMEM, SimCYP, R, SAS etc.) ・Solid understanding of clinical trial documents (synopsis, protocols, study reports etc), briefing document, CTD and their processes and excellent writing skill to demonstrate CP concepts clearly. ・Excellent communications skills, including logical thinking and facilitation skills, in Japanese and English demonstrated by the ability to explain complex CP concepts to influence senior leaders in the formulation of CP strategy and direction. 【Technical / Functional (Line) Expertise】・Experience in clinical development of pharmaceuticals ・Broad knowledge and experiences of Clinical Pharmacology including Pharmacokinetic Analysis, Population PK analysis and modeling and simulation. ・Knowledge of pharmaceutical regulations in and outside Japan (ICH, Pharmaceutical Affairs Law, GCP, Notification of Clinical Trial Notification, etc.) ・Ability to solve problems through different approaches from various perspectives ・Project management techniques and business knowledge, methods for improving business processes, and creation of ideas
アピールポイント	自社サービス・製品あり日系グローバル企業女性管理職実績あり上場企業従業員数1000人以上創立30年以上年間休日120日以上産休・育休取得実績ありストックオプション制度あり教育・研修制度充実資格支援制度充実管理職・マネージャー完全土日休み
リモートワーク	可「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策	屋内禁煙
更新日	2025/03/28
求人番号	4440204

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武田薬品工業株式会社

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