Country-level Development Team Leader

A global pharmaceutical company is seeking a Regional/Country-level Development Team Leader. The selected candidate will lead development teams and manage all aspects of clinical planning, design, and regulatory submission processes.

Responsibilities:

• Lead cross-functional development teams and ensure alignment across internal and external stakeholders
• Develop and implement Clinical Development Plans (CDPs), including study design and protocol strategy
• Guide protocol development and oversee the preparation of study-related documents and scientific publications
• Drive data analysis and interpretation, ensuring accurate efficacy and safety evaluations
• Represent the company in meetings with regulatory authorities, partners, and key opinion leaders
• Oversee regulatory submission processes including CTDs, CTNs, and NDAs
• Provide technical guidance to operations teams and manage project risks
• Mentor junior staff and contribute to building clinical development excellence in the region

Requirements:

• Bachelor’s degree or above
• More than 7 years of experience in biopharmaceutical clinical development
• Prior experience in protocol development, regulatory submissions, and managing multiple clinical studies
• Experience in health authority consultation
• Knowledge in relevant therapeutic areas
• Proficient in global clinical development practices and regulatory requirements
• Ability to lead project management and stakeholder engagement
• Proficient in written and verbal Japanese and English

About the Company:

A global pharmaceutical organisation that delivers cutting-edge products and services to meet patient needs. With employees in several countries, this is an excellent company to work for.

Keywords:

臨床開発, 開発リード, 医薬品業界, 治験, 規制対応, プロトコル作成, チームマネジメント, プロジェクトマネジメント, データ解析, 提出書類対応, 求人, 外資系

Job Ref: 0A295A