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

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 multiple perspectives, including differentiation versus competitors, pricing, distribution, and overall business viability. The senior CDS leads global proposals and discussions, not only from a Japan optimization perspective, but also with a view to what is meaningful for the global organization. The senior CDS participates as an equal partner in global meetings such as AST and TAPR, and helps drive consensus. Even when no prior global development plan exists, the senior CDS is expected to lead the development of a plan from Japan and guide it toward agreement with global teams and regulatory authorities. The senior CDS also conducts strategic clinical assessments for in-licensed products. 競合との差別化、薬価、流通、事業性等を含む複数の視点を加味した、製品価値最大化につながる臨床開発戦略オプションを設計し、グローバルに提案し，議論を主導する。日本での開発の最適化に加え、グローバル全体にとって意義のある提案を行い、グローバル会議（AST，TAPR等）で対等に議論し、合意形成を促進する。先行するグローバル開発が存在しない場合も、日本主導で開発計画を策定し、グローバルおよび規制当局の合意に導く。導入品の評価で戦略的な臨床評価を実施する。   In the event of issues with medical institutions, regulatory authorities, or other external parties, including major concerns, major errors, serious complaints, or unexpected serious adverse events, the senior CDS is responsible for bringing together the relevant functions, such as TAMD/SD, Safety, CSM, Regulatory Affairs, and JASL, to resolve the matter appropriately on behalf of the company. When necessary, the senior CDS leads the design of discussions, organizes the decision-making process, and develops measures to prevent recurrence. 医療機関、規制当局等とのトラブル（重大な懸念やエラー、重大なクレーム、予期しない重篤事象等）に対し、関連部門（TAMD/SD、安全性、CSM、薬事、JASL 等）を統率し、会社として適切な方法で解決に導く責任を負う。必要に応じて、議論の設計、判断プロセスの整理、再発防止策の策定をリードする。   During the study, the Senior CDS shall: Senior CDSは治験期間中，以下を実施する： In collaborate with Clinical Site Management (CSM) to ensure that overall study timelines are met. Clinical Site Management (CSM) と治験の全体的なタイムラインの確実な履行に協働する。 Collaborate with TAMD/SD, the PST Lead, Safety, and CSM to ensure the safety of subjects in Japan. TAMD/SD，PST Lead，安全性部門，CSMと協働し，日本の被験者の安全性の確保に努める。 Prepare key study documents, including the scientific rationale document and clinical study report, or work collaboratively in their preparation. 治験に関する主要な文書（科学的妥当性文書，治験総括報告書を含む）を自ら作成する，または，協働のうえ作成する。 Lead the JAST Clinical Working Team. JASTのClinical Working Teamのリードをする。   The Senior CDS collaborates with relevant departments in accordance with the JD Medical Collaboration Guidance (publication, Investigator Forum, etc.). Senior CDSはJDメディカルコラボレーションガイダンスに基づき関連部署と協働する（パブリケーション，Investigator Forumなど）。   The CDS provides appropriate information and education to internal staff as needed. Senior CDSは必要に応じて社内スタッフに適切な情報提供及び教育を行う。 Senior CDS Conducts the above responsibilities without CDH support. Educates lower grade CDS/associate and A-MD with CDH.