Clinical Leader (Clinical Development Scientist I / II), Solid Tumor Oncology

企業概要 About AbbVie AbbVie's 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 people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube. 求人内容 ※The expected offer grade is 17 or 18 (Depending on the candidate's experience as well as interview evaluation)  Purpose Statement: The Clinical Development Scientist (CDS), as the leader of clinical development in Japan, is responsible for clinical matters and works with internal and external stakeholders to plan, manage, and execute clinical development strategies based on medical and scientific rationale and regulatory considerations, in order to deliver novel pharmaceutical product and medical devices to patients as early and efficiently as possible.  クリニカルディベロップメントサイエンティスト（CDS）は，日本での臨床開発のリーダーとして，臨床に関する事項について責任を負い，社内外のステークスホルダーと協働し，医学的，科学的根拠並びに薬事的観点に基づき，新しい医薬品や医療機器を可能な限り早く効率的に患者さんに届けるための臨床開発戦略を立案・管理・実行する。 Major Responsibilities: The CDS collects and understands the information necessary to formulate clinical development strategies. Specifically, through managing external key opinion leaders (KOLs) and collecting information at academic conferences, etc., the CDS identifies unmet medical needs in Japanese medical practice. The CDS also understands PMDA review trends, the global development strategy for the assigned asset, and the development status of competing products. CDSは，臨床開発戦略策定に必要な情報を収集し，理解する。特に，社外のキーオピニオンリーダー（KOL）のマネジメントや学会での情報の収集等を通じ，日本の医療現場でのアンメットメディカルニーズを把握する。また，PMDAの審査トレンドや担当薬剤のグローバルの開発戦略，さらには競合製品の開発状況についても把握する。   As the representative of clinical development, the CDS leads the preparation of the Japan Clinical Development Plan (JCDP) that addresses Japan’s regulatory requirements and clinically feasible unmet medical needs, in accordance with the TPP, and contributes to maximizing product value. In addition, the CDS leads discussions on clinically related matters to reach agreement with Global during the preparation of the JCDP. CDSは，臨床開発の責任者として，TPPに沿った薬事規制及び臨床的に実現可能性のある日本のアンメットメディカルニーズを満たすJapan Clinical Development Plan (JCDP）の作成をリードし，製品の価値最大化に貢献する。また，JCDPの作成過程でのグローバルとの合意形成時に臨床に関連する内容のディスカッションをリードする。   The CDS leads major discussions with Global and relevant regulatory authorities on clinical issues arising during the development process, including Meeting with global team and PMDA preliminary and/or official consultation, to reach agreement. In the event of conflict, the CDS proposes the most appropriate solution and works with relevant stakeholders to resolve it. CDSは，開発の過程で発生する臨床に関する課題に対して，グローバル及び関連する規制当局との主要な協議（グローバルチームとの会議，PMDAとの対面助言や事前相談含む）をリードし，合意を形成する。また，コンフリクトが発生した際は，最適な解決策を提案し，関連するステークホルダーと協働のうえ解消に努める。   The CDS accurately interprets the clinical study results obtained and develops a submission strategy based on scientifically compelling evidence. The CDS also prepares the clinical section of the CTD and responds to inquiries from the regulatory authorities, taking relevant surrounding information into consideration. CDSは，得られた臨床試験結果を正しく解釈し，科学的に説得力のある根拠に基づいた申請戦略をたてる。また，関連する周辺情報を加味してCTDの臨床パートの作成や規制当局からの照会事項に対応する。   During the study, the CDS shall: CDSは治験期間中，以下を実施する： (a) In collaboration with monitoring team, oversee the reliable execution of the overall study timelines. モニタリングチームと協働し，治験の全体的なタイムラインの確実な履行を監督す (b) Collaborate with internal medical expert and scientist, safety management group, and monitoring team to ensure the safety of subjects in Japan 社内の医学専門家やサイエンティスト，安全性部門及びモニタリングチームと協働し，日本の被験者の安全性の確保に努める。 (c)Prepare key study documents, including the scientific rationale document and clinical study r