■What to do：
Project Related Medical/Safety Support:
◇Minimize potential risk to X and clients by managing medical aspects of contracted tasks. This includes, but is not limited to, medical monitoring of all safety variables （AE, laboratory abnormalities, changes in patient medical status as well as inclusion/exclusion criteria, evaluation prescribed concomitant medication for protocol restrictions and unblinding requests）. Scope of work also includes discussion internally with medical monitors in Japan, APAC and global and project team colleagues internally, as well as with principal investigators and clients of all medical issues during the course of a study by proper medical judgment, interpretation and decision.
◇Medical review of serious adverse events.
◇Ensure tasks delegated to medical monitors are properly executed. Adhere to applicable regulations and ICH guidances regarding clinical trials, regulatory documents, and safety issues. Adhere to client SOPs/directives and project specific WPDs for assigned projects. Adhere to X’s corporate policies and SOPs/WPDs.
◇Present X standard medical processes to clients at business development meetings, investigator meetings, and communicate with various medical communities to explore and expand X business.
◇Provide medical consultation to team members and help manage protocol related medical questions. Communicate clearly with project team members and clients, maintaining open communication to ensure all procedures are followed appropriately.
Provide therapeutic training and protocol training on assigned studies, as requested.
◇Perform listing reviews as specified in the client contract and data validation manual, including review of coding listings and/or full safety listings as well as use of Patient Profiles and other tools to assess for potential safety signal.
◇This position will be assigned to APAC components of global or regional studies. Including but not limited to global/regional studies with Japan component. This person will also take care of a major responsibility of ICCC review, therapeutic area training to clinical team in X, supporting business development in X, and clients requests including F2F visits to investigators, KOLs and sites in Japan.
【必須（MUST）】■Academic Qualification: －MD degree
■Required Knowledge and skill:
－ A certified license of a medical doctor.
－ Experience in hospital settings for at least 5 years, with a specialty of oncology, neuroscience, psychiatry, immunology, infectious disease physician are all very welcome.
－ Be able to work both in a Japan organization and a regional/global environment.
－ Experience in regulatory authority or pharma would be a plus, but not a must.
■Language: Both Japanese and English proficiency.