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GPKOL
임상 인허가
미국
R & D기획
R & D기획 임상
R & D기획 인허가
일본
- R&D : 연구/개발 전략 & 기획 : IP 전략 - 인허가 : 일본 인허가 전략 수립 : 후생성, PMDA communication 업무(통역) : 문서 작성 업무 : 일본 문서(규정) 번역
인허가
중국
- 의약품 등록/판매허가 - 국제협력 프로그램 - 식품안전관리조정
R&D기획 1. drug discovery and development/ lead optimization/pharmacology/PK&PD/biomarkers and diagnostics/toxicology/pharmaceutics(CMC)/clinical development and regulatory requirements for small molecule and therapeutic antibody 2. Expertise in research strategic planning and mangement of projects 3. strong experience in building and constructing business plan and managing start-up biotech company(co-founder of PharmAbcine) 4. strong industry experiences in global biotech and pharmaceutical companies including Chiron (currently Novartis), AstraWeneca, Genentech and Exelixis 임상 1. IND, clinical protocol, investigator brochure 작성 2. leading clinical management/operation 3. biomarkers and diagnostic strategy in clinical trials
기술마케팅
A biochemist and molecular biologist with 15 years of pharmaceutical and biotechnology company experience focusing on protein biochemistry, assay development, and drug discovery in the areas of oncology and metabolic diseases. Extensive experience in preclinical research and lead optimization for small molecule drugs as well as protein therapeutics with project leading and team management.
- Oncology/ Gynecology Oncology - Drug Development - Clinical Research - Medical Affairs - Health Outcomes - Health Care Management
