Clinical Scientist, Associate Director, R&D Division

About the role

Alexion Japan is looking for an Associate Director Clinical Scientist within its R&D division. The role contributes to the therapeutic area strategy through research of the medical environment, engagement with key opinion leaders (KEEs) and planning of advisory board meetings, while acting as a point of contact for global clinical development experts.

Key responsibilities

• Participate in program meetings and give expert opinions to support team discussions and decisions
• Act as a point of contact for global clinical development experts
• Review and give expert input on program documents such as protocols and investigator brochures (IB)
• Review and give expert input on regulatory interaction documents (e.g. briefing documents for the PMDA, orphan drug designation applications) and on filing documents (CTD, J-PI, RMP)
• Prepare responses to the clinical part of PMDA inquiries together with JPTL and other JPT members
• Contribute to discussions with the PADG team and review publication strategy and quality
• In the case of a Japan stand-alone study, create study documents such as a protocol concept sheet

Required profile

• At least eight years of experience in drug development in pharmaceuticals, biopharmaceuticals or biotechnology
• Experience in Phase 1 to 3 clinical work as a clinical scientist (preferred)
• Extensive clinical scientist experience including KEE engagement, advisory board meetings, clinical document preparation, regulatory interactions, filing preparation and post-filing inquiry resolution
• Knowledge of local regulations and guidelines
• English skills sufficient to communicate with a global team
• Bachelor's degree in life sciences