臨床開発リーダー/ Clinical Development Lead

A foreign pharmaceutical company is looking for a Clinical Development Lead. The selected applicant will be responsible for driving the clinical development of assigned assets in Japan.

Responsibilities:

• Lead Japan clinical development programs, including design, execution, and optimisation of CDPs in collaboration with Global Asset Team and relevant functions
• Provide strategic input and ensure alignment of Japan CDPs with target product profiles, regulatory requirements, and market access considerations
• Integrate clinical, medical, regulatory, and operational insights to reduce protocol complexity and optimise study design
• Oversee study execution, ensuring data quality, safety, efficacy evaluation, and benefit-risk assessments
• Lead DT-J for assigned assets within a matrix organisation, driving alignment with global teams
• Contribute to the preparation and delivery of clinical components of regulatory submissions, including briefing documents, protocols, CSRs, and responses to health authority inquiries
• Represent and justify Japan's clinical development strategy to governance bodies, regulatory authorities, and strategic partners
• Develop and maintain strong networks with external stakeholders such as regulators, investigators, key opinion leaders, and patient advocacy groups
• Support market access, commercialisation, and maintenance of product licenses in Japan
• Provide drug development and therapeutic expertise for business development, including evaluation of in-licensing opportunities
• Present at conferences, symposia, and investigator meetings as a medical/scientific expert
• Ensure audit/inspection readiness and compliance with ICH GCP, SOPs, and applicable quality standards
• Share clinical program knowledge across the organisation and apply lessons learned to future programs

Requirements:

• Bachelor's degree pr above in life science or healthcare (Master's, PhD, Law (J.D.), Medical Degree (M.D.), or PharmD is preferred)
• More than 5 years of experience in biopharmaceutical clinical development
• Experience in strategic design of global clinical programs, oversight of the planning and simultaneous delivery of multiple clinical studies, attendance at meetings with regulatory authorities and applicable external stakeholders and clinical contribution to regulatory submissions and life cycle management
• Knowledge of all aspects of global or Japan clinical development
• Regulatory and compliance knowledge
• Previously led a part or an entire clinical is preferred
• Proficient in 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:

製薬, 医療, 臨床, 外資系

Job Ref: 37CA92B8