An international pharmaceutical company is looking for an Immunology Clinical Japan Head. The chosen applicant will be responsible for leading clinical program activities, working closely with both local and global teams.
Responsibilities:
- Play a medical lead role in Japan-initiated studies in collaboration with GPCH or CDMD
- Lead the development and execution of clinical strategy post-Drug Development Point
- Provide input to the creation of clinical components of key documents
- Contribute interactions with external stakeholders and internal decision boards to lead clinical-related health authority activities
- Contribute to the development of Immunology strategies
- Support publication and clinical communication strategy in coordination with MA Japan and Medical Writing
- Lead or serve on process improvement work streams
- Act as subject matter expert for standard operating procedures or training
Requirements:
- Advanced degree in life sciences or healthcare (or clinically relevant degree: MD or equivalent, PhD, PharmD degree is preferable)
- Specialisation in a subspecialty (Immunology)
- Advanced clinical training or knowledge in the medical or scientific area
- More than 5 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers
- Knowledge of GCP and GPSP, clinical trial design, statistics, and regulatory or clinical development process
- Experience with submissions or health authorities
- Proficient in Japanese; business level written and verbal English
About the Company:
One of the world's largest providers of medical treatments for a variety of human and animal diseases. Headquartered in Europe, the company has a strong global network that is dedicated to improving people's lives.
Keywords:
ヘルスケア, 医療, 臨床, ライフサイエンス, 研究, 製薬, 外資系
2041520/001
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