Clinical Development Scientist, Neurology

Job Description

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.

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.

b)    Taking part in the study safety monitoring, in collaboration with internal medical expert and safety management group.

c)    Preparing core clinical documents, including the Clinical Study Report.

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.

CDSを教育する。

CDS II (G17)

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。

Qualifications

Background / Experience

5年以上、もしくはそれに相当する臨床開発知識

Education

Leadership Behavior / Mindset

Knowledge

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

Skill

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer / Veterans / Disabled.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

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