メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

日本における臨床開発の戦略立案と運営を担い、科学的知見と実務経験を活かして治験サイトとの連携や患者登録の促進を推進します。
地域やグローバルチームと協働し、疾病動向や競合情報を踏まえた実現可能性評価を行い、プロトコール設計や試験配置に反映。主要意見リーダーやサイトとの関係構築を通じて患者募集を最適化し、臨床開発、規制、医療関係部門と連携して統合戦略を策定・実行します。課題予測と解決策提案、チームメンバーの指導も担当し、臨床試験の成功に貢献します。

■休日：完全週休二日制, 年末年始

Qualification Required:
Education Required:
Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred. Minimum of 10 years of experience in clinical development within the pharmaceutical or biotechnology industry

Computer Skills:   
Efficient in Microsoft Word, Excel, and Outlook  
Familiar with industry CTMS and data management systems  

Qualifications:   
At least 10 years of experience in clinical research area.
Solid project management experience is preferred.
Multi-National Company or Global CRO experience is preferred.
3+ years of clinical monitoring experience.
Therapeutic or medical knowledge is preferred
Experience in data analysis, data interpretation to drive inform decision making.
Proven abilities in leadership and the mentoring junior colleagues.
Comprehensive understanding of clinical trial processes and thorough knowledge of ICH-GCP guidelines and applicable regulations.
Excellent interpersonal, organizational, and communication skills. Fluency in written and verbal English is essential.
Proficient computer skills, including Microsoft Word, Excel, Outlook, and understanding of industry

Travel Requirements:
Adaptable to business trips as needed, with a travel time of up to 15-25%.

Competencies:
Scientific knowledge and operational acumen
Cross-functional collaboration and communication
Relationship building and stakeholder management
Proactive leadership and strategic foresight
Analytical and critical thinking skills

■職種未経験者：不可