Joseph Kim
- Role
- Vice President - Quantitative Clinical Development at Parexel
- Location
- Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
Experience
Vice President - Quantitative Clinical Development
Jan 2020 — Present
Consulting clinical pharmacologist, PK modeling and simulation expert. Involved in various stages of clinical trials from first time in human studies (FTIH) to Phase IV studies. Designed and executed multiple clinical studies including preparation of study protocols and analyzing the PK data and writing clinical study report for regulatory submission (FDA and EMEA). Worked on diverse therapeutic area: HIV/AIDS, Hepatitis C treatment compound, HBV, Diabetes compound, Hepatic Fibrosis treatment compound, Oncology compounds, Diabetes compounds, Biologicals, Anti Sense Oligonucleotides (ASO), Supportive care compounds. Provide PK/TK input to the pre-clinical, DMPK and toxicological study team. Support Project Team and Clinical Matrix Team regarding clinical studies and clinical development (study design, dose selection, dose escalation, PK/PD modeling and simulation, Regulatory response writing etc.). Managing group of PhD level PK scientists. Work with Business Development in client facing meetings. Manage modeling and simulation project teams. Internal and expert PK, PK/PD modeling and clinical drug development subject matter expert.
Skills
- Protocol
- Monte Carlo Simulation
- Clinical Study Design
- Pharmacokinetics
- Clinical Development
- Life Sciences
- Fda
- R&D
- Pharmacodynamics
- Oncology
- Mathematical Modeling
- Clinical Research
- Clinical Pharmacology
- Quantitative Risk Analysis
- Drug Discovery
- Drug Development
- Pharmacology
- Clinical Trials
- Pharmaceutical Industry
- Biotechnology
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