Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology 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 Senior Clinical Development Scientist (Senior CDS) is a highly specialized clinical development professional in Japan, responsible for leading clinical development activities end to end, from strategy planning through regulatory approval, across therapeutic areas. Compared with the CDS I/II, the senior CDS has broader scope of authority and responsibility. The Senior CDS is expected to oversee multiple projects simultaneously and to exercise sound judgment in novel, complex, or highly uncertain situations. In doing so, the senior CDS integrates medical and scientific evidence with regulatory requirements, business impact, and implications for clinical practice to define and execute optimal development strategies. The senior CDS also serves as a key contributor in cross-functional and external discussions, engaging as an equal partner with other departments, global teams, physicians, healthcare institutions, academic societies, and regulatory authorities to drive decision-making and consensus building. In the absence of an established global development plan, the senior CDS is expected to formulate a development strategy from the Japan perspective, secure alignment with global teams and regulatory authorities, and lead implementation. シニアクリニカルディベロップメント サイエンティスト（Senior CDS）は、日本での臨床開発の高度専門職として、疾患領域を問わず、臨床開発戦略の立案から承認取得までを臨床開発の責任者として一貫して主導する。CDSI/IIより広い裁量と責任範囲を持ち、複数プロジェクトを統括するとともに、前例がない、または不確実性の高い状況でも、医学・科学的根拠に加え、規制要件、ビジネスインパクト、医療現場への影響を統合した総合判断を行い、最適な開発戦略を立案・実行する。また、他部門、グローバルチーム、医師・医療機関、学会、規制当局と対等に交渉し、意思決定および合意形成を主導する。先行するグローバル開発計画が存在しない場合でも、日本の視点から開発戦略を構想・計画化し、グローバルおよび規制当局の合意を得て実行に移す。 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 leader responsible for 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 the IEST, Global Study Team Meeting 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