Alexion JapanClinical Scientist, Associate Director, R&D Division
At a glance
Why this role might suit you
The role offers deep involvement in Japan's clinical development landscape, regulatory navigation, and global collaboration within a leading pharmaceutical company.
Skills
About the role
Location: Japan Job reference: R-256227 Date posted: 07/13/2026
Principal Responsibilities
Contribute to the TA strategy through researching the medical environment, identifying and building relationships with KEEs, and through the planning, preparation of advisory board meetings.
Participate in program meetings to stay updated on the latest progress and provide expert opinions as needed to support team discussion and decision-making.
Act as a point of contact for global clinical development expert
Review and provide expert input on program related documents (e.g. protocol, IB)
Review and/or provide expert input on documents for regulatory interactions (e.g. briefing document for PMDA, Orphan drug designation application)
Review and provide expert input on relevant parts of filing documents (e.g. CTD, J-PI, RMP).
Prepare responses to clinical part of PMDA inquiries in collaboration with JPTL and other JPT members.
Contribute to discussion of PADG team in collaboration with JPTL and medical affairs.
Review and expert input on publication strategy and contents/quality of publications.
(In case of a Japan stand-alone study) create study documents (e.g. protocol concept sheet)
Qualifications
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.
(Preferred) Experience working in a global pharmaceutical company
Extensive experience as a clinical scientist including KEEs engagement, AdB meetings, preparation of clinical documents (e.g. protocol, IB), regulatory interactions, filing preparation and post-filing inquiry resolution.
Knowledge of local regulations and guidances
English skills that enables communication with global team.
Education
Life Science related bachelor’s degree
Others
Business Trip Available; Visit to mainly domestic medical institutions/doctors, domestic conferences, etc.
Date Posted
13-7月-2026
Closing Date
11-7月-2027
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