The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate. As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams
役割・職務の概要 Clinical Development Scientist（CDS）は、日本における臨床開発プロジェクトの推進および承認取得に貢献する役割を担います。 開発プロジェクトをリードしているJapan Development Leadと連携し、臨床試験の計画・実施から承認申請まで一貫して関与するとともに、グローバル組織との連携を通じて臨床試験に関するプロセスの効率化や日本の開発組織の価値最大化に貢献します。 本ポジションでは、臨床開発に関する知識・スキル・経験を活かしてプロジェクトに貢献するとともに、さらに臨床開発に関わる総合的な能力を高め、将来的にDevelopment Japan内の多様な役割で活躍する基盤の構築も期待されます。 今回、募集するポジションは、内科系疾患（とくに循環器・代謝疾患）領域のプロジェクトのCDSです。 主な業務内容 各疾患領域において、臨床開発プログラム（第1相試験〜承認申請・承認取得まで）の推進 臨床試験関連文書の作成・レビュー （例：治験実施計画書、同意説明文書、CRF） 承認申請および規制当局対応に関する文書作成支援（例：CSR、CTD、PMDA相談資料、照会事項対応） Japan Development Leadのサポートによる臨床試験の円滑な遂行 患者報告アウトカム（PRO）等、新規手法やツールの導入・活用 臨床開発計画立案および臨床試験遂行に必要な情報の調査・提供 グローバルチームおよび関連部門との連携による臨床試験の情報共有・精度向上 臨床開発のプロセスの改善およびSOP整備への貢献 臨床・統計・臨床薬理担当者の連携による定量的意思決定の推進 主な関係部署・ステークホルダー 社外 治験実施医療機関・治験責任医師 規制当局（PMDA等） 社外医学専門家・学会 社内 臨床試験実施部門 統計解析部門 プロジェクトマネジメント部門 メディカルライティング 薬事部門 メディカル・マーケティング部門 Global Project Team 等 応募資格 必須要件
Clinical Development Lead (CDL) is responsible for the overall Japan clinical development plan for assigned projects. CDL ensures studies are designed to fit Japan specific requirement and situation from clinical, regulatory, and operational perspectives. CDL is accountable for planning and execution
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Clinical Leader YOUR TASKS AND RESPONSIBILITIES: Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related
Clinical Leader YOUR TASKS AND RESPONSIBILITIES: Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related
General Information Job Advert Title: Clinical Transparency & Disclosure Scientist Location: Nihonbashi, Tokyo Division: Clinical Operations, Quantitative Sciences and China Development Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development solution
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every clinical development solution
JOB DESCRIPTION: Primary Function Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages clinical project team
Job Purpose At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive
Basic Purpose of the Job The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set-up, execution and delivery of assigned clinical trials at the Japan level. Key responsibilities: Accurate planning and efficient trial execution
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Summary of purpose/major responsibilities The Clinical Operations and Study Leader (COSL) combines Clinical project and study oversight roles and responsibilities for Vaccines projects activities. For projects activities (project and study oversight, CTD submission, PAI…), the COSL will cover
Get to know us Ideals is a global B2B SaaS product company recognized as the most highly rated and customer-centric brand in the secure business collaboration market. Trusted by over 2,000,000 users from 300,000 companies globally,
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our