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)
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
Basic purpose of the job enior CPhL-Asia supports the clinical development in Asia of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP)development strategy. CPhL-Asia
Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining
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 is
Job Overview: The Clinical Trial Manager II has ownership in the clinical delivery and operational oversight of clinical research trials. This role collaborates with project managers and other functional leads to deliver clinical and start-up activities
Job Purpose Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of
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
Director IPH 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, agility, and inclusion are at
The role of Regulatory Operations Manager manages the regulatory operation process including regulatory authority (RA) submissions and approval according to ICH-GCP guidelines, local regulatory requirements, Novotech / client standard operating procedures (SOPs), and the project agreement.
Responsibilities: • CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. • Foster internal and external
Job Overview: Site Navigators II plays a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point
Job Overview: Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point
About SecurityScorecard: SecurityScorecard is the global leader in cybersecurity ratings, with over 12 million companies continuously rated, operating in 64 countries. Founded in 2013 by security and risk experts Dr. Alex Yampolskiy and Sam Kassoumeh and
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
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of
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
Job Description 職務内容 オンコロジー領域の複数品目の早期、後期開発プロジェクトの要となるJapan Clinical Directorを募集しております。 業務内容としては早期、後期開発のプロジェクト・リード、臨床試験実施のための社内外における折衝（社内関連部署、CRO、KOLとの折衝）及び進捗管理、海外グローバルチーム・カウンターパートとの協業、薬事部門との協働による規制当局への対応、パブリケーション業務等を行います。 今後の面接を通じてご本人のご興味、これまでの経験などを加味し、適切な業務にアサインしていくことを考えております。 Oncology領域の早期、後期開発のプロジェクト・リード 戦略的開発計画の立案、プロトール考案、総括報告書作成の業務マネジメント 臨床試験実施のための社内外における折衝（社内関連部署、CRO、KOLとの折衝）及び進捗管理 海外グローバルチーム・カウンターパートとの協業 規制当局への対応 アドバイザリー・ボード関連業務 ・国内開発等に関するアドバイザリー・ボード会議の企画立案、運営 ・グローバル研究開発に関連するアドバイザリー・ボード会議関連業務（研究者の推薦・支援等） 規制当局への対応業務 当局提出資料の作成、照会事項回答作成とレビュー、当局相談への臨床担当としての出席と議論 パブリケーション関連業務 ・パブリケーション・プランの作成、パブリケーションに関するプロセス管理 ・製品に関する総説等の論文執筆 ・国内および国際学会における科学的・医学的情報収集活動 ・医師・医療関係者とグローバル本社間での科学的・医学的エンゲージメント活動の支援・管理 応募資格 ＜教育＞ 理系修士号（必須）、薬剤師資格（尚可） 医学、薬学、看護学、または自然科学分野における、博士号保持者（尚可） ＜語学力＞ ネイティブレベルの日本語力（必須） ビジネスレベルの英語力：グローバル部門関係者と、科学的・医学的ならびにビジネス一般の討議および日常業務がスムーズにできること（必須）。特に、ビジネスレベルの会話能力を有すること。 ＜経験・知識・スキル・能力＞ 製薬会社でのOncology領域プロジェクトリーダーとしての臨床開発実務および承認申請業務の経験者（必須） Oncology領域における疾患知識（必須） 高い倫理観を有し、関連する法規制、ガイドライン・ガイダンス等々に関する確実な理解および知識を基にした、バランスあるコンプライアンス判断能力を有すること。 戦略的および論理的な思考能力を有すると共に、サイエンスならびにオペレーションの両面で確実な実務能力・スキルを発揮できること。 クロス・ファンクショナル、クロス・ボーダーな組織および仕事環境のもとでの就業経験。 がん領域における国内医師、研究者、医療関係者とのネットワークを持ち、対外的に優れた影響力を発揮できること。 社内（国内・外）関連部門及び外部専門医との密接な協働作業のために必要な確立された対人対話能力およびプレゼンテーションスキル。
Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering