【alexion Japan】clinical Scientist Associate Director R D Division Minato Ku Tokyo Japan

Job description

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 04-8月-2025 Closing Date 12-7月-2027 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.