外資系製薬会社

Associate Director of Clinical Research Scientist｜クリニカルリサーチサイエンティスト Associate Director
Location: Tokyo｜勤務地：東京

1. Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.
2. Provides scientific support to their functions including but not limited to their Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs. Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner.
3. Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support their development programs.
4. Responsible for the design of Japanese clinical research studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols.
5. Prepares and presents (if applicable) scientific information concerning their development programs internally and at external meetings as required.
6. Critically assesses requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials and Grant requests:
7. Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings. Attends and presents their position at informal and official Consultation meetings with PMDA and MHLW.
8. Working with Regulatory Affairs and the respective the Project Team, prepares written responses to PMDA, MHLW and IRB queries.
9. Coordinates the preparation and/or review of regulatory documentation including but not limited to IND annual reports, IND safety reports, Investigator Brochures, and J-NDAs.

Mandatory:
1. Japanese Fluent
2. MS degree or above.
3. Minimum of 5 years of experience within clinical research
4. Experience in inflammation therapeutics including rheumatoid arthritis and IBD is preferable.
5. Experience in preparation for and attendance at PMDA/MHLW consultation meetings.
6. Direct experience in the preparation and filing of CTNs, J-NDAs and other clinical research documentation.
7. Current, working knowledge of ICH and local guidelines and PMDA/MHLW notifications.
8. Good communication and discussion skills to build and maintain working relationships with Japanese physician and research scientists.
9. Strong organizational skills and ability to manage multiple projects simultaneously.
10. Fluency in oral and written English.

Report line: the Head of Clinical Research Japan
The Clinical Research Scientist plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for their development compounds, especially in inflammation therapeutic area.
Although generally assigned to a specific therapeutic area, the Clinical Research Scientist may support local clinical research activities across development programs.