Clinical Pharmacology Scientist

6日前

Minato 711 GlaxoSmithKline K.K. Full time

Job Purpose:

The CPMS Asia/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 Discovery & Development(MID3)を適用します。

Key Responsibilities:

  • Ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice of Modeling & Simulation (M&S) and application of Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds.
  • 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.
  • 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.
  • 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.
  • Support long term strategic initiatives in the development of innovative MID3 solutions to complex R&D problems.
  • 薬物動態(PK)、薬力学(PD)を適切に用いて、効率的な医薬品開発、リスク管理及び承認申請に向けて、Modeling & Simulation(M&S)の実践とModel Informed Drug Discovery & Development(MID3)の適用
  • アジアおよびグローバルのメンバーとして、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Model Informed Drug Discovery & Development(MID3)の適用
  • 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に対する内因性および外因性の潜在的影響の評価を含む臨床薬理試験の解釈
  • 臨床薬理における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
  • 複雑な研究開発の問題に対する革新的なMID3を用いた開発における長期的な戦略的イニシアチブをサポート

    • ※職務内容および勤務地の変更範囲は会社の定めるところとする。

    必要な条件 / Basic Qualification:

    スキル Skill:

    Clinical Pharmacology Knowledge

  • 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 a 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.

    • MID3

  • Has proficiency in the application of general clinical pharmacology and pharmacometrics skillset components associated with MID3 i.e. perform the analysis, interpretation and reporting of empirical and mechanistic population PK/PD

    • 臨床薬理

  • 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に習熟している。
  • 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、臨床薬理学に習熟している。

    • MID3

  • 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に習熟していること(母集団PK及びPK/PD解析の実施、解釈および報告を行うなど)

    • 経験 / Experience:

  • Has an understanding of how to develop and implemented regulatory strategies related to MID3 and /or clinical pharmacology in general. ; Including Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
  • MID3および臨床薬理学全般に関する規制戦略の立案と実施について理解している。CTA、IND、NDA、MAA、BLAなどの薬事申請文書に精通している。

    • 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

    • 望ましい条件 / Preferred Qualification:

    スキルおよび経験 Skill and Experience:

  • Has gained proficiency in deeper scientific knowledge related to associated areas e.g. Ethnopharmacology, pharmacogenetics, Drug metabolism,
  • Has gained proficiency in an understanding of a disease area(s) of focus for GSK e.g Oncology, Immunology/Respiratory and Infectious disease/Vaccines.
  • Has gained proficiency in the deployment of MID3 within the context of decision making within a regulatory agency or pharmaceutical company.
  • Has proficiency in development and implementation of regulatory strategies related to MID3 and or clinical pharmacology in general.
  • Is developing or has proficiency in the application of general clinical pharmacology and pharmacometrics skillset components associated with MID3 i.e. perform the analysis, interpretation and reporting of empirical and mechanistic population PK/PD, Model Based Meta-analysis, Disease progression modelling and associated simulations; including a working knowledge of common tools for quantitative clinical pharmacology such as NONMEM.
  • 民族薬理学、薬理遺伝学、薬物代謝学などの関連分野に関する科学的知識を習熟している。
  • GSKが注力する疾患領域(癌、免疫・呼吸器、感染症・ワクチンなど)を理解している。
  • 規制当局や製薬業界における意思決定におけるMID3の適用に習熟している。
  • MID3および臨床薬理学全般に関する開発戦略の立案と実践に習熟している。
  • 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に習熟している。すなわち、母集団PKおよびPK/PD解析、Model Based Meta-analysis、疾患モデルおよび関連するシミュレーションの実施、解釈および報告を行う。また、NONMEMなどの臨床薬理に関連するソフトウェアの知識を有する。

    • 学位/資格/語学力 Education/certification/Language:

  • Relevant experience in clinical pharmacokinetics/modelling and simulation/drug development
  • Relevant Clinical pharmacology experience
  • 臨床薬物動態学/ Modeling & Simulation /医薬品開発における関連する経験
  • 臨床薬理学の経験

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