PK specialist

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MAIN FOCUS AND MISSION:

Leveraging the latest insights in pharmacokinetics (PK) and pharmacodynamics (PD), we apply advanced kinetic analysis to drive efficient drug development, regulatory registration and maximize compound value

最新の薬物動態学及び薬力学に基づき、速度論的解析を駆使して、効率的な医薬品開発、承認申請及び化合物の価値最大化に貢献する。

ROLE & RESPONSIBILITIES:

・Evaluating PK/PD data related to international/domestic clinical and non-clinical studies according to ICH guidelines & regulatory notifications and regulatory interaction for development and registration of new medicinal products in Japan

ICHガイドライン/当局通知および当局交渉に準拠し、本邦での新医薬品開発および承認申請に向け、各種臨床試験および非臨床試験に関連するPK/PD関連データの評価を実施

・Authoring and reviewing clinical pharmacology-related documents in English/Japanese for New Drug Application (NDA) including CTD Module 1 [Package insert]and Module 2, Clinical Trial Notification related documents, briefing books for consultation meetings and those responses for health authorities (PMDA/MHLW)

下記当局（PMDA/厚生労働省）対応に必要な臨床薬理関連文書（英語・日本語）の作成およびレビュー
－ CTD Module 1 [添付文書] and Module 2
― 治験計画届に関連する資料、対面助言等相談資料 および 回答資料

・Supporting preparation of promotional materials, etc. for medicinal products in the post-marketing phase

市販後における医薬品プロモーション資材等の作成支援

・Communicating with subject matter experts in global clinical pharmacology team in Servier group

セルヴィエグループ海外臨床薬理専門家チームとのコミュニケーション

YOUR PROFILE:

Advanced degree in medical, pharmaceutical or life-science
（Bachelor‘s degree or higher）

学士以上、分野;  医学、薬学、または生命科学

・Work experience in R&D of pharmaceutical companies, CROs or research institutes for around 5 years or more, especially practical experiences of pharmacokinetic analysis in clinical development or clinical research 

製薬会社、開発受託機関または研究機関での研究開発部門にて約5年以上の経験あり、特に臨床開発または臨床研究における薬物動態解析の実務経験あり

・Experience in handling NDA, HA consultation in Japan

本邦において医薬品承認申請、治験相談業務に参画した経験あり

Hard skills/ Expertise:

・Understand non-compartment/compartment model analysis, Population PK analysis, PK/PD analysis, PBPK modeling approach, and DDI, etc. in global drug development considering local requirements

ローカル要求事項も考慮したグローバル医薬品開発における薬物動態の知識：ノンコンパートメント解析、コンパートメントモデル解析、母集団薬物動態解析、暴露ー反応解析、生理学的薬物速度論モデル、薬物相互作用等

・Native level of Japanese, including reading and writing, and English language skills that do not interfere with reading and writing (oral English skills do not need to be fluent but no obstacles to communicate orally)日本語：native level、英語：business level

・Be familiar enough with the handling of MS WORD, Excel, PowerPoint

ソフトウェア：ワード、エクセル、パワーポイント

[Preferable]

・Experience and knowledge of non-clinical pharmacology studies and/or experience and knowledge of non-clinical toxicity tests

非臨床薬理又は非臨床毒性試験の知識または業務経験あり

Soft skills:

・A person who has a mindset of cross-functional teamwork

組織内・組織間のメンバーと連携するチームワーク

・A person able to perform with growth mindset to difficult situations

困難の状況におかれてもグロースマインドセットにて行動する

・A person able to propose themselves and respond flexibly from a clinical pharmacology point of view to achieve important milestones of drug development and registration

医薬品開発・申請において臨床薬理専門家としてフレキシブルな判断と適切な提案が自らできる

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.