17431 Clinical Research Manager/Director【Oncology】
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 the functions including but not limited to 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 the 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 the 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 (ISTs) and Grant requests:
7) Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings. Attends and presents the company’s position at informal and official Consultation meetings with PMDA and MHLW.
8) Working with Regulatory Affairs and the respective 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.
1) MS degree or above.
2) Minimum of 3-7 years of experience (depending on the grade) within clinical research /clinical development.
3) Experiences in preparing the CTD and query responses in JNDA.
4) Leadership and project management skill to drive clinical development of new therapies in Japan.
5) Communication skill enabling timely information sharing with Foster City and other functions at the company.
6) Problem solving skill to analyze the problem and develop/execute action plans.
7) Medical writing skill to prepare study protocols and regulatory documents related to clinical.
8) Negotiation skill with investigators and officials in the Health Authorities to move the study forward.
9) Deep knowledge of clinical guidelines and regulatory requirements.
10) Extensive experiences in clinical development to put together the best and fastest development strategy.
11) Up-to-date expertise in the responsible therapeutic area