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更新日 2018-04-05
掲載開始日 2018-04-04

Clinical Pharmacologist

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人材紹介
Michael Page Japan
企業名 Joint Venture Between Leading Japanese Pharma Maker and Top 5 US CRO
職種
Michael Page Japan
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種 製薬メーカー
勤務地 アジア 日本 東京都

仕事内容 * Contribute to the approval of new life-changing drugs in the Japanese market through creation of CTD
* Communicate with PMDA regarding document preparation, review and consultation of clinical pharmacology related sections of CTD


Description

* Clinical pharmacology / clinical pharmacokinetic work in drug development

* Planning, implementation and reporting of pharmacokinetic analysis (including population pharmacokinetic analysis and modelling & simulation) in clinical trials (phase 1 to phase 3, post-marketing clinical trial)

* Creation of CTD (Modules 2.7.1 and 2.7.2)

* Response to authorities (document preparation, review or consultation of clinical pharmacology related part etc)

* Planning or planning from the clinical pharmacological aspects of the development plan of the project in charge or consulting at planning

* Consulting at planning or planning Phase 1 and clinical pharmacology studies

* Clinical pharmacological planning in late-stage clinical trials or consulting at planning


Profile

* Experience in phase 1 study and planning of clinical pharmacology, pharmacokinetic analysis using Phoenix WinNonlin, experience of CTD production, etc.

* Work experience in population pharmacokinetic analysis, physiological pharmacokinetic analysis
Experience of programming with analysis software (SAS, S-PLUS, R etc)

* Preferable to have experience in oncology clinical development


Job Offer

* Join a growing company with strong opportunities for career development in

* Strengthen skills in clinical pharmacology area

* Work on drug development for multiple TAs including oncology and CNS


Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について
(社風など)
* Joint venture between leading Japanese pharma maker and top 5 US CRO
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Clinical Pharmacologist

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