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Manager in Clinical Development Group, TA-Oncology, CDMA(TSM140825)

業種Pharmaceutical
職種Manager in Clinical Development Group, TA-Oncology, CDMA
雇用形態Senior staff ~ Manager position
仕事内容■Mission
Strengthen our products’ profile by providing medical/scientific robust guidance in the responsible projects through the total process of the clinical development phases, in collaboration with the corporate, other department in CDMQ division, KPRI and Marketing.

■Accountabilities
1.Responsible for making Japanese clinical development plan recognized by our global medicine as well aligned with global development strategy in the respective therapeutic area
2.Ensure Japanese submission(s) and registration(s) in the respective therapeutic area are appropriately handled and obtained
3.Ensure all the projects in the therapeutic area are correctly managed in both in timeline and in quality
4.Support Japan office make development/data building decision based on total picture (all projects/trials in the respects of resource/budget) in the therapeutic area
5.Support us obtains preferable pricing in Japan
6.Knowledge transfer to Medical Affairs function and other relevant business function(s)
7.Assure Re-examination dossier of launched product(s) in charge
資格M.D. or Ph.D. would be highly appreciated
必要な経験・スキル1.Experience
.More than 10 years experience of the oncology in either clinical development or clinical practice
.Having job experience of project leader and/or project manager in clinical development in pharmaceutical company(ies)
.Having successful J-NDA experience in oncology, preferably hematological malignancy indication
.Preferably having opinion leader network in oncology/hematology

2.Knowledge
.Medical knowledge in oncology/hematology
.GCP & GPSP regulation and related SOPs
.Excellent interpersonal skills: communication, influencing, team-building
.Strong logical and strategic thinking
.English writing & presentation

3.Qualification
.M.D. or Ph.D. would be highly appreciated

4. Required International Communication Skills Level
.Successfully handles complex work tasks with minimal misunderstanding
給与10mil~+bonus
勤務地Shinagawa-ku, Tokyo
勤務時間・残業8:45~17:20
待遇Social Insurance etc.
休日・休暇Saturdays and Sundays
その他
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