Manager, Clinical Pharmacology Modelling & Simulation

GSK (Tokyo, 日本) フォロー 15時間前

Job Purpose:

The CPMS Asia/Japan Manager 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.
臨床薬理及びモデリング&シミュレーション（CPMS）Asia/Japanマネジャーは、グラクソ・スミスクライン（GSK）の開発品の治療および製品開発について、臨床薬物動態学（PK）、薬力学（PD）を用いて、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）を適用することに貢献します。

Key Responsibilities:

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.
Promote long term strategic initiatives in the development of innovative MID3 solutions to complex R&D problems.

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
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）
5-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 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.
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
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.

臨床薬理学またはファーマコメトリクス分野での5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）
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。

<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

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 an understanding of how to develop and implemented regulatory strategies related to clinical pharmacology and MID3 in general, Including Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
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.
Coach, train, and develop other MID3 specialists and CPMS leads as appropriate.

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。
臨床薬理学およびMID3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。
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。
他のMID3スペシャリストやCPMSリードの指導、トレーニング、育成を行える。

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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