Karim Lee, Ph.D, PMP

Experience

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  Seoul National University

  Sept 2005 - Feb 2008

  Senior Researcher

  1. Lead international collaborative project: Development of anti-HIV gene therapy strategy using novelendoribonuclease (collaboration with TaKaRa Bio, Japan)2. Lead industrial research project: Construction of retroviral vectors with enhanced safety andefficiency for gene therapy (supported by industry research fund)

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  University of California, San Francisco

  Apr 2008 - Aug 2012

  Postdoctoral Fellow

  Preclinical study for Treg therapy using murine transplantation model

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  UCSF Health

  Sept 2012 - Jul 2018

  Accelerated promotion, 5 years1. Manufacturing supervisor in UCSF Clinical Treg Therapy Program: Lead member of Tregmanufacturing team supporting at least 5 clinical trials2. Lead UCSF Transplantation Immune Monitoring Study Core: Plan, design, implement mechanisticstudies for at least 6 clinical trials3. Cross-functional teamwork: Closely interact/communicate with principal investigators, medicaldirectors, nurses, clinical research coordinators, quality assurance officers, regulatory affairmanagers, CROs, vendors, etc. Show less 1. Development of GMP-compliant processes for manufacturing human alloantigen-reactive Tregs(arTreg) for Treg cell therapy clinical trials in transplantation2. Contribution to IND/DMF/protocol amendment submission related CMC process development andvalidation (authored at least 7 study reports, 10 SOPs, 5 qualification plans)3. Participation in multi-centered international clinical trial (supported by European Consortium) as localimmune monitoring lead scientist: Lead mechanistic study at UCSF and collaborate with central corelab in Germany Show less

  • Specialist

    Jul 2015 - Jul 2018

  • Associate Specialist

    Sept 2012 - Jul 2015
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  Gilead Sciences

  Jul 2018 - now

  Clinical Trial Management, Biomarker Operation