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
Basic Purpose of the Job The Clinical Program Leader assumes Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Programme Team Leader. The Clinical Program Leader has a medical leadership
企業概要 Santenは、眼科医療に特化した130年の歴史を持つ製薬企業です。日本発のグローバル企業として60カ国以上に拠点を持ち、目の健康のために様々な革新的な治療法とデジタルソリューションを提供し、世界中の人々の視覚に関わる社会問題に取り組んでいます。 日本アジア臨床開発グループは、参天製薬の開発プロジェクトにおいて臨床試験の実行を担う中核組織です。試験の立ち上げから終了まで、施設選定、ベンダーマネジメント、リスク管理、品質確保、試験進捗管理等、臨床試験運営全般をリードしています。私たちは日本、アジアをはじめとする各地域の専門家と連携し、多様な知識と経験を結集して世界水準の臨床試験を推進しています。患者さんを中心に据えた開発を通じて、眼科医療の未来を切り拓くことが私たちの使命です。 求人内容 担当PJに関する薬効評価、規制要件等の各種情報を収集するため、自律的に臨床開発戦略に従った臨床開発計画、臨床試験及びモニタリング計画を立案する。 CRA/ベンダーを適切にマネジメントし、科学性、倫理性、信頼性の確保されたデータを期限内に収集する。 治験進捗を管理・分析し、対策を立案・実行することで、臨床試験を速やかに進捗させる。 収集した科学性、倫理性、信頼性の確保されたデータを基に、総括報告書等の臨床試験関連資料（案）を作成する。 臨床試験実施を通じて、医学専門家等と良好な信頼関係を構築する。 資格 ICH-GCP及び関連規制要件に関する深い知識を有すること 臨床試験デザイン、評価項目、薬効評価等に関する理解を有すること モニタリング実務経験を有し、試験運営戦略を立案できること CRO及びベンダーマネジメント経験を有すること 試験進捗、品質、予算、リスクを総合的に管理できること 英語による文書作成やコミュニケーション等の業務遂行能力を有すること その他の情報 Santenにおけるキャリア構築 Santenでのキャリアは、あなたにとって変化をもたらす機会となります。Santenは、「Santen2030」に示されている長期的ビジョンを通じて、視覚障害者の社会的・経済的ニーズに応える社会イノベーターとなることを目指しています。そのために私たちは、世界中のチームメンバーと多様な才能を発揮し合い、柔軟な働き方とインクルーシブな職場環境を提供しております。その結果、新たなソリューションを発見し、患者様への理解、治療の革新を推進しています。 Santenグループは、Equal Opportunity Employerです。 私たちは、多様なチームを構築し、チームメンバー一人ひとりにとって安全でインクルーシブな物理的・仮想的職場を提供することを約束します。すべての雇用は、人種、肌の色、民族、出身/祖先、宗教、性的指向、性別、性同一性/表現、年齢、障害、病状、配偶者の有無、退役軍人の有無、または法律で保護されているその他の特性に関係なく、ビジネスニーズ、役割要件、個人のスキルセットに基づいて行われます。...
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Job Purpose The Clinical Scientist (CS) in Japan is responsible and accountable for clinical scientific outputs for assigned projects and studies in Japan. The CS will have accountability for approximately 2 - 4 projects (assets) at any one
Job Description 1. Objectives Responsible for clinical development of the assigned project in Japan under the supervision of the Japan Development Leader (JDL), who assumes responsibility for development of all projects in Japan in the respective therapeutic/disease
Job Purpose The Clinical Development Lead (CDL) in Japan is the single point of accountability for all clinical development activities for assigned asset(s). The CDL provides scientific and medical leadership to define and deliver Japan clinical strategy, drives innovation
General Information Job Advert Title: Clinical Site Manager Ⅲ（臨床開発モニター/ Site Monitor/ CRA） 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
Career CategoryClinical Development Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all
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
Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors
Job Description Summary-Planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. May interact with investigational sites, clinical consultants, Contract Research Organizations & other vendors. Collaborates with Country medical/clinical colleagues, global clinical teams and directs activities to execute
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve
Title: Senior Quality Specialist Location: Japan HQ - About the job As Senior Quality Specialist (Expert Japan) within our Vaccine R&D Quality Operations team, youll lead all quality-related activities for Vaccine R&D in Japan, ensuring compliance with
Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people
Company Description PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across
Manager, FSA - Tokyo Osaka - Office Hybrid/Home ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration,
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring