||* Project and lead for early and late development, including anti-PD-1 antibody in Oncology field
* Planning for strategic development plan, design of protocol, devising report Preparation of work on
* internal and external negotiation for internal clinical trial department, CRO, negotiations with KOL) and progress management
* cooperation with overseas global team counterpart
* corresponding to the regulatory authorities
* Lead the development of Oncology projects (early and late phase) for our anti-PD-1 Ab and other projects.
* Development of strategic plans, protocol plans and managing Clinical Study Reports (CSRs).
* Communication with internal / external stakeholders (w / functions within the company, CROs, and external KOLs) and managing clinical trials.
* Collaboration with global teams / counterparts
* Communication with PMDA / MHLW, functioning as a clinical leader and working with regulatory colleagues