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

AbbVie · Minato City, Tokyo, Japan

  • Senior
  • Full-time
  • Posted 2026-09-02
  • Confirmed live on 25 September 2026

Apply at AbbVie

Job description

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当局との主要な協議（IEST/Global Study Teamや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。

• Compared with the CDS I/II, the senior CDS manages multiple more complex projects, sets priorities, manages risks, and is responsible for achieving key milestones. If another CDS responsible for a project becomes unavailable, the senior CDS is expected to step in immediately and continue decision-making, external coordination, and project management without interruption.

CDS I/IIと比較して、より複雑なプロジェクトを複数統括し，優先順位付け、リスク管理を行い、主要マイルストン達成に責任を負う。他のプロジェクト担当CDSが不在となった場合、即時に代替対応し、意思決定、対外折衝、プロジェクト運営を継続して遂行する。

• In situations that are unprecedented or highly uncertain, the senior CDS organizes options, assesses risks and impact, including regulatory, business, and clinical practice implications, and provides direction. Senior CDS also ensures that necessary decisions and communications are carried out promptly.

前例がない、または不確実性の高い状況において、選択肢を整理し、規制・ビジネス・医療現場への影響を含めたリスクとインパクトを評価した上で方向性を提示し、必要な意思決定やコミュニケーションを迅速に行う。

• The senior CDS designs clinical development strategy options that maximize product value by considering multip

Prepare for the interview

Nothing collected for this employer yet. The Blind 75 is what technical screens draw from; practise it here, with a coach, in Java or Python.

More at AbbVie

More like this

All open software jobs