Ruojing Li
Director, Quantitative Pharmacology and Pharmacometrics at Merck | Former FDA reviewer and team leader in pharmacometrics/clinical pharmacology
- Role
- Clinical Pharmacology Team Leader at FDA
- Location
- Fairfax, VA, US
- LinkedIn followers
- 500 followers
About Ruojing Li
9-year of experience in clinical pharmacology and pharmacometrics. Experienced in multiple therapeutic areas including rare diseases, hematology oncology, anti-viral and anti-infectives, and gastroenterology.Extensive hands on experience with population PK analyses (NONMEM) and exposure-response analyses (R). Comprehensive knowledge in clinical pharmacology strategies with both small molecules and large molecules, including dose selection for adults and pediatrics, drug-drug interactions, food effect, immunogenicity, organ impairment, etc.
Experience
Clinical Pharmacology Team Leader
Oct 2022 — Present · Silver Spring, MD, US
Comprehensive regulatory and scientific knowledge in clinical pharmacology strategies for clinical development (Phase I, II and including dose selection and optimization (including pediatrics), drug interaction studies, organ impairment studies, food effect studies, biomarker evaluation, etc.• Leading clinical pharmacology reviews and regulatory decision making for IND, NDA and BLA applications.• Closely working with multiple disciplines in a dynamic and fast-paced environment• Team management and leadership, new team member training• Actively participating in FDA guidance development• Multiple internal and external presentations
Education
Peking University
Bachelor of Science (B.S.), Pharmaceutical Sciences
2005 — 2009
The Johns Hopkins University School of Medicine
Doctor of Philosophy (Ph.D.), Pharmacology
2011 — 2016
Peking University
Master of Science (MS), Pharmaceutics
2009 — 2011
Skills
- Western Blotting
- Confocal Microscopy
- Molecular Biology
- Fluorescence Microscopy
- Protein Chemistry
- Pcr
- Nmr
- Molecular Cloning
- Medicinal Chemistry
- Science
- Life Sciences
- Assay Development
- Cell Based Assays
- Statistics
- Biotechnology
- Protein Purification
- Research
- Drug Discovery
- Organic Synthesis
- Biochemistry
- Nuclear Magnetic Resonance (Nmr)
- Mouse Models
- Cell
- Pharmacology
- Cell Culture
- Data Analysis
- Chemistry
- Immunoprecipitation
- Microscopy
- High-Performance Liquid Chromatography (Hplc)
- Hplc
- Microsoft Office
- Cell Biology
- Purification
- Protein Expression
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