Japan Development Team Lead for Immunology/臨床開発リーダー 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2017年 06月 22日

求人情報

臨床開発リーダー

求人管理No.011247

会社概要

Japan Development Team Lead for Immunology

割り当てられたプロジェクト(心臓血管/免疫学)の責任者として、高品質の治療領域戦略とタイムラインに沿った開発計画を実行する業務。

募集要項

・Has the accountability of the development strategy for an asset
・As a responsible person in assigned projects (Cardiovascular/ Immunology ), demonstrates strong leadership to execute development plans aligned with therapeutic area strategy and timeline with high standard of quality.
・Engages and collaborates with global/alliance counterpart to align with global strategy as a representative of in assigned therapeutic area.
・Oversights team’s activities to ensure quality of execution.
・Provide input to senior leadership team for effective decision-making and execution.
・Reports to Cardiovascular / Immunology JDTL (D7)

役割:
・Provide Matrix leadership to create the overall development strategy for an asset
・Based on the input a d direction from Cardiovascular / Immunology JDTL (D7), creates and ensures execution of the overall clinical development plan for an asset or assets in Cardiovascular/ Immunology.
・Solicits and integrates input from statistics, regulatory, outcomes research, medical, commercial and other experts. Ensures that studies are aligned with target label indications and commercial goals, and are properly designed and conducted in a timely and cost efficient manner.
・Oversees the review of safety and efficacy data across the program and integrates this information in order to detect relevant patterns and makes study modifications or start/stop recommendations as needed. Provides timely updates to the Cardiovascular / Immunology JDTL (D7) in Japan and governance boards.
・Responsible for the creation of key study documents (e.g., integrated summaries of safety and efficacy).
・Initiates, develops and maintains key relationships with internal and external stakeholders.
・Has accountability for filing strategy and responsibility for considering regulatory strategy (e.g. JPI and Japan HA interaction strategy etc.) with regulatory strategy lead
・Selects, leads, develops, motivates and achieves results through teams.
・Provides Matrix leadership for integrated team of professionals who are responsible for all components of study design and execution.
・Oversees Phase 1 Phase 3 studies
・Provides medical and scientific expertise to colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments. Provides scientific/medical input to, and reviews various study plans which are implemented by the Operations group. Advises creative solutions for operational obstacles. Provides medical/scientific perspective regarding pricing, reimbursement, quality of life, publications needed at launch, lifecycle management etc. in order to achieve the program’s commercial

募集条件

  • ・A minimum of 5 years of clinical development / industry experience preferred
    ・Expertise in design, execution, analysis and publication of Phase II-III clinical trials
    ・Experience with clinical components of regulatory submissions and clinical presentations to regulatory authorities
    ・Overseeing Phase 1 Phase 3 studies, with demonstrated decision making capabilities
    ・Broad, in-depth knowledge of both clinical and medical science within assigned therapeutic area
    ・Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation.
    ・Knowledge of the drug development process.
    ・Knowledge of the components needed for an effective clinical plan and protocols.
    ・Strong leadership skills with proven ability to lead and work effectively in a team environment.

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし

給与

  • ご経験に応じての額となります。