Clinical Development Director
Tokyo 23 Wards
Join an Industry Leading Global Pharmaceutical Company
Drive R&D Project Planning and Execution across the Company
About Our Client
- US bio-pharmaceutical company with rich development pipeline across Oncology, Infectious Diseases and Vaccines and Immunology TAs
- Act as local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.
- Provide scientific support to functional teams including Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs.
- Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support clinical development programs.
- 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.
- Prepare and present (if applicable) scientific information concerning clinical development programs internally and at external meetings as required.
- Critically assess requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials (ISTs) and Grant requests.
- Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings.
- Work with Regulatory Affairs and the respective Project Teams, prepare written responses to PMDA, MHLW and IRB queries.
- 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.
The Successful Applicant
- MS degree or above
- 5+years' experience within clinical research / clinical development
- Experiences in preparing the CTD and query responses in JNDA
- Leadership and project management skill to drive clinical development of new therapies in Japan
- Problem solving skill to analyze the problem and develop/execute action plans
- Medical writing skill to prepare study protocols and regulatory documents related to clinical
- Negotiation skill with investigators and officials in the Health Authorities to move the study forward
- Deep knowledge of clinical guidelines and regulatory requirements
- Extensive experiences in clinical development to put together the best and fastest development strategy
- Up-to-date expertise in the responsible therapeutic area
What's on Offer
- Strong development pipeline across Oncology, Infectious Diseases and Vaccines and Immunology
- Report directly to the Head of Clinical Development
- Lean organization, flat structure within Japan - ability to make your voice heard