人材紹介Michael Page Japan
|企業名||Global Oncology Focused Pharmaceutical Company|
メディカル/医薬/バイオ/素材/食品 - 臨床開発系
* Work with Global Early Clinical Development team and Japan Project Team to develop clinical trial protocol and translation for local and global trials
Build and manage effective relationship with key investigators to optimise scientific quality and innovation of clinical trials in terms of design, execution, reporting, and publication
* Lead Clinical Trial Team and report directly to Head of Translational Clinical Oncology
* Lead start-up activities of clinical trials, manage scientific aspects of regulatory processes, work closely with PMDA and select and manage CRO/vendors
* Build and manage relationship with key investigators to optimise scientific quality/innovation of clinical study design, execution, reporting, and publication.
* Work closely with HQ to ensure team is in line with global standards of performance and quality. Chair meetings for clinical trial team and report study progress and issues with a resolution plan.
* Lead medical/scientific review, final analysis and interpretation of clinical trial data, including development of clinical study reports, publications, etc.
* Manage time-line, budget and human resources for clinical oncology trials.
* In new projects and existing projects planned in the future, proceed with clinical trials according to protocol and take charge of a series of research and development work until completion.
* Solid experience in planning, executing, reporting and publishing clinical studies
* Experiences in oncology early clinical development preferred
* Good knowledge of GCP, clinical trial design, and drug development processes including regulatory processes
* Basic knowledge of oncology/haematology
* Good communication and team management skills
* Native level Japanese, business level English
* Opportunity to develop career in oncology clinical development and help to bring innovative new medicines to the Japan public by working on global clinical trials
* Utilise your passion for clinical development in a top 5 company in the oncology/haematology area
Page Group Japan is acting as an Employment Agency in relation to this vacancy.
* Top 5 global pharmaceutical company
* One of the global leaders in development of innovative medicines drugs for oncology area
|年収||日本・円 1000万円 〜 1300万円|