Clinical Development Lead - Japan

About the role

Biogen is hiring a Clinical Development Lead (CDL) in Tokyo. The CDL owns the overall Japan clinical development plan for assigned projects, ensuring studies are designed to meet Japan-specific clinical, regulatory and operational needs. The role is a management position and involves leading communication with external stakeholders such as investigators, regulators, key medical experts and academic societies.

Key responsibilities

• Develop the Integrated Development Plan (IDP) and the Japan clinical development strategy, and ensure it aligns with the global strategy
• Provide the regional development team with information on the disease landscape, SOC, KMEs and competitors in Japan
• Lead clinical studies as owner of the studies, ensuring protocols fit Japanese medical practice and managing local amendments
• Secure resources and budget with the CTM, and be accountable for CRO and vendor selection and study budget
• Identify study-level risks and drive risk mitigation, and manage study issues including AEs with the Study Medical Director and Safety Physician
• Prepare and review clinical content of regulatory submissions and responses to regulatory queries, and take part in regulatory consultations
• Act as a local clinical representative in regulatory interactions and lead scientific discussions with investigators and KMEs
• Build scientific reputation in academic societies through conferences, presentations and publications

Required profile

• Bachelor's degree or equivalent; MD/PhD/PharmD preferred
• Clinical development experience in the biopharmaceutical industry of at least 3 years in product development
• Experience with regulatory agencies (PMDA experience preferred)
• Leadership, team-building and strategic thinking skills, with excellent oral and written English