【Alexion Japan】Clinical Scientist, Associate Director, R&D Division

The Clinical Scientist, Associate Director, R&D Division will contribute to the TA strategy, participate in program meetings, and act as a point of contact for global clinical development expert. They will review and provide expert input on program related documents, regulatory interactions, and filing documents. They will also prepare responses to clinical part of PMDA inquiries and contribute to discussion of PADG team.

Requirements

• Minimum of eight (8) years of experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.
• Experience in Phases 1 to 3 as a clinical scientist.
• Experience working in a global pharmaceutical company (preferred)
• Extensive experience as a clinical scientist including KEEs engagement, AdB meetings, preparation of clinical documents, regulatory interactions, filing preparation and post-filing inquiry resolution.
• Knowledge of local regulations and guidances
• English skills that enables communication with global team

Benefits

• Business Trip Available