Japan Clinical Leader (Pharmaceutical R&D)

Location: Tokyo, Japan; hybrid

Employment type: Full time

Company

Global pharmaceutical company focused on research, clinical development, and regulatory approval of medicines.

What you will do

• Lead clinical development activities for assigned projects in Japan under the Japan Development Leader.
• Formulate Japan development plans and contribute to global development strategies, including biomarker, diagnostic, medical practice, and regulatory considerations.
• Lead Japan Development Teams and clinical studies in cooperation with global research and development teams.
• Build relationships with internal and external stakeholders, including key opinion leaders, academic societies, and patient groups.
• Prepare and review clinical and regulatory documents, including study outlines, protocols, CTD materials, publications, and post-approval risk management documents.
• Review clinical and safety data, manage protocol deviations, and lead independent data monitoring, adjudication, and safety review committees.

Requirements

• Scientific educational background and more than 3 years of clinical development experience.
• Thorough understanding of clinical development processes and regulatory submissions.
• Ability to design and execute development strategies using medical and pharmaceutical knowledge, clinical study operations expertise, logical thinking, and strong writing skills.
• Leadership, team building, networking, negotiation, consensus building, problem-solving, and project management skills.
• Excellent written and verbal communication skills in both Japanese and English.
• Experience contributing to pharmaceutical R&D studies, multiple projects, and medium-sized cross-functional teams.

Culture & Benefits

• Hybrid work arrangement in Tokyo, Japan.
• Collaboration with Japanese and global research, development, and business teams.
• Opportunity to improve clinical development practices and implement new approaches.
• Work with internal and external scientific, medical, regulatory, and patient stakeholders.