Site Name: Japan - Tokyo - Akasaka Posted Date: Mar 13 2025 Job Purpose The CPMS Japan Lead will provide technical therapeutic, and product development support for GlaxoSmithKline projects. Individuals will ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice of Modeling & Simulation (MS) and optimal application of Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds. CPMSリードは、グラクソ・スミスクラインの開発品において、治療および製品開発の技術的なサポートを提供します。臨床薬物動態学（PK）、薬力学（PD）を適切に用いて、Modeling & Simulation（M&S）の実践に習熟し、効率的な医薬品開発、リスク管理、承認申請に向けてModel Informed Drug Development（MIDD）を適用します。 Key Responsibilities Contribute to the design of an efficient clinical development program and a robust registration package for the Asia region and specifically Japan. Design the component of the Asia Phase 1 PK/PD strategy and associated study design elements within the assigned therapeutic area(s). Analyze and interpret clinical pharmacology studies, including those to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics. Work as member of both Asian CPMS and global CPMS teams to develop and deliver Model Informed Drug Development Modelling and Simulation strategies to impact project strategy, decision making and accelerated approvals. Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators. Innovate through working effectively with colleagues in the department and others such as statisticians, physicians, and regulatory affair staffs. アジア地域、特に日本における効率的な臨床開発プログラムおよび臨床データパッケージの設計 担当領域におけるアジアの第I相試験の必要要件および関連する試験デザインを提案 PKおよびPDに対する内因性・外因性の潜在的影響の評価を含む臨床薬理試験の解釈 アジアおよびグローバルのCPMSメンバーとして、プロジェクト開発戦略、意思決定、承認取得の促進に影響を与えるMID3の適用 臨床薬理戦略および結果を社内ガバナンス委員会および規制当局に提示・説明 社内外のステークホルダーと効果的に協力し、変革を推進 必要な条件Basic Qualification <スキル及び経験 Skill & Experience > Clinical Pharmacology & MID3 Knowledge（臨床薬理およびMID3の知識） 3-year or more experience in Clinical Pharmacology or Pharmacometrics area. Has developed a proficiency in scientific concepts associated with the practice and application of clinical pharmacology in terms of principles of pharmacokinetics and pharmacodynamics as this relates to R&D and therapeutics. Has developed proficiency in clinical pharmacology in terms of understanding basic design principles, analysis, interpretation and reporting of Clinical PK and PK/PD studies including Phase 1 ethnic sensitivity studies. Has in the application of general clinical pharmacology and pharmacometrics skillset components associated with MID3 臨床薬理学またはファーマコメトリクス分野での3年以上の業務経験。 開発および疾患に関連するPKおよびPDの指針に基づき、臨床薬理学の実践と応用を理解している。 民族差を検討する第I相試験、臨床PKおよびPK/PD試験の基本的原則、解析、解釈および報告に関して、臨床薬理学を理解している。 MID3に関連する臨床薬理学およびファーマコメトリクスの適用を理解している。 <学位/資格/語学力 Education/certification/Language> Graduate degree of medical, pharmaceutical, life science or taken enough training for clinical field. English reading comprehension, writing skills for English documents, and excellent communication skills in English that enable deep discussion with global relevant members. 医療系、薬学系または生命科学系大学の学部卒以上。又は臨床領域において十分な訓練を受けた者。 英文の読解力、英文資料作成、Global memberとの協議・交渉ができる英語力 Why GSK? 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