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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
求人内容 Purpose Statement:
Clinical Development Scientist (CDS), as the leader of clinical development in Japan, contributes to the development, management and execution of the clinical development strategy based on medical, scientific and regulatory principles, in collaboration with internal and external stakeholders, for the purpose of delivering the most efficient clinical development strategy to achieve the fastest approval of the responsible asset.
クリニカルディベロップメントサイエンティスト(CDS)は、日本における臨床開発のリーダーとして、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、最も効率的且つ迅速な臨床開発戦略を立案・管理・実行する。
Major Responsibilities:
1.
CDS, as the representative of the clinical development team, is responsible for developing the clinical development strategy, including the clinical data package and clinical study design, and conducts the associated key regulatory discussions, including face-to-face advice and prior interviews with the PMDA.
CDSは臨床開発責任者として、臨床開発戦略（臨床データパッケージ及び治験デザインを含む）を策定し、関連する規制当局との主要な協議（PMDAとの対面助言や事前相談含む）を実施する。
2.
During the course of a clinical study, CDS is responsible for:
CDSは治験期間中、以下を実施する：
(a) The oversight of the clinical studies, and review, interpretation, and communication of
accumulating data pertaining to safety and efficacy of the molecule. In collaboration with
the monitoring team, CDS is responsible for the oversight of overall timelines for key
deliverables.
治験中に得られた有効性及び安全性に関わる情報を確認、考察、伝達し、治験を監
督する。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を監督する。
(b) Taking part in the study safety monitoring, in collaboration with internal medical expert and
safety management group.
社内の医学専門家及び安全性部門と協働し、治験の安全性モニタリングに参加す
る。
(c) Preparing core clinical documents, including the Clinical Study Report.
治験に関する主要な文書(治験総括報告書を含む)を作成する。
3. CDS prepares the clinical part of CTD and deal with the associated inquiries from the regulatory
authorities.
CDSはCTDの臨床パートを作成し、関連する規制当局からの照会事項に対応する。
4. CDS is responsible for the development of the core contents of publications including
presentations at academic conferences and manuscripts.
CDSはパブリケーション（学会等の発表資料・論文作成等を含む）の主要な内容の責任
者としてその作成又は確認を行う。
5. CDS acts as the clinical interface and actively solicits key opinion leader (KOL) interactions;
partners with cross-functional team members including cross-functional team leader, Medical
Affairs, Commercial and other functions in these activities as required, to ensure that broad
cross-funcitonal perspectives are incorporated into the development, management and
execution of the clinical development strategy.
CDSは、社外の医学専門家(KOL)より臨床開発戦略上必要な見解を得るための窓口とな
る。また、CDSは臨床開発戦略の立案・管理・実行に関連部署それぞれの観点を適切に
取り入れるべく、クロスファンクショナルチームリーダー、医学統括部、コマーシャル
部等を含むクロスファンクショナルチームメンバーと連携する。
6. CDS oversees project-related education for local AbbVie study staff as appropriate, in
consideration of local medical/scientific environment.
CDS は国内の医学的・科学的状況を考慮の上、必要に応じて社内スタッフに適切な教育
が行われていることを監督する。
CDS I (G16)
•Conducts the above responsibilities with his/her superior’s minimum oversight/support.
•Educates lower grade CDS/associate CDS with his/her superior.
上司の最小限の監督/支援を受けながら、上記の責任を遂行する。
上位者とともに、下位のCDSを教育する。
CDS II (G17)
•Conducts the above responsibilities without CDH oversight/support.
•Educates lower grade CDS/associate with CDH.
CDHの最小限の監督/支援を受けずに、上記の責任を遂行する。
CDHとともに、下位のCDSを教育する。
マインド Leadership Behavior/Mindset
•Set Vision ビジョンと戦略を設定する
•Anticipate 将来を予見して行動する
•Innovate 革新を促す
•Build 築き上げる
•Deliver Results 確実に成果をもたらす
知識 Knowledge
•Clinical Development experience for assigned therapeutic area, equivalent clinical knowledge, and/or capability to acquire equivalent knowledge.
担当領域における開発経験、もしくはそれに相当する臨床知識及び/又はこれらの知識を習得する能力
•TOEIC is 800 score or higher, or equivalent skill for English communication.
TOEIC 800点以上、もしくはそれに相当する英語コミュニケーション力
スキル Skill
•Leadership
•Coaching
•Team building
•Communication (in Japanese and English)
•Facilitation
•Medical writing
アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。
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