Mikhail Rojavin
- Role
- Senior Scientific Director, Clinical Development at Amgen
- Location
- Southampton, PA, US
- LinkedIn followers
- 500 followers
About Mikhail Rojavin
Clinical researcher with 20+ years of collaborative experience in global pharmaceutical…
Experience
Senior Scientific Director, Clinical Development
Oct 2023 — Present
Horizon was acquired by Amgen in October 2023
Education
Ukrainian National Academy of Siences
Ph.D., Microbiology
1979 — 1982
Kiev State University
M.S; master's thesis, microbiology and immunology
1974 — 1979
Temple University - Lewis Katz School of Medicine
PostDoc, Pharmacology
1991 — 1993
Skills
- Good Clinical Practice (Gcp)
- Ema
- Pmda
- Patient Reported Outcomes
- Patient Recruitment
- Clinical Development
- Protocol Experience
- Bla Submissions
- Drug Development
- Phase 1
- Post-Marketing Studies
- Medical Affairs
- Phase 3
- Pharmaceutical Industry
- Gastroenterology
- CRO
- Hrql
- Biotechnology
- Clinical Research
- U.s. Food and Drug Administration (Fda)
- Pharmacoeconomics
- Study Reports
- CRO Management
- Pk
- Integrated Database
- Fda
- Popular Science
- Clinical Study Design
- Clinical Project Management
- Registry Studies
- Conference Presentations
- Phase 4
- Regulatory Requirements
- Ctd Preparation
- Ich-Gcp
- Time Management
- Pooling
- Medical Writing
- Ctms
- Phase 2
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