Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology

Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology 正規雇用 Workday Global Grade: 18 会社概要 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.