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Immunologist Resume Example

Resume Score: 70%

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IMMUNOLOGIST
Executive Profile

•Diplomate of the American Board of Toxicology

•Over twenty years of professional experience in medicine, biomaterials, biocompatibility, immunology, including pharmacology and toxicology with more than 20 peer-reviewed publications;

•Six years of the FDA experience including two years Pharmacology/Toxicology reviewer in CDER and four years immunologist/consulting reviewer/principle investigator in CDRH involved in products approval processes;

•Broad array of knowledge in pharmacology/toxicology, biomarkers, medicine, immunology, tissue engineering, biomaterials, stem cells, molecular-cell biology and animal modeling in range from mechanistic approaches, preclinical safety assessment to a variety of clinical applications;

•Thorough knowledge and techniques in basic biology, medical and regulatory sciences/standard/guidance

•Developed and conducted purpose-specific research protocols to address specific safety concerns for industries in the enhancement of their approvability.

Skill Highlights
  • Hands-on experiences in human material based/clinically relevant/non-animal derived biomarker identification and development for preclinical safety evaluation, clinical monitoring and risk management, facilitate regulatory standards and guidance update;
  • Active membership of the Society of Toxicology, Biocompatibility Standards Technical Group, Nitinol Interest Group, Nanotech Reviewer Network and Renal Biomarker Qualification Team;
  • Formal the FDA regulatory training, research training in toxicology and clinical practice in USA, Japan and China;
  • Excellent capability in teamwork and communications, team management, science based creativity e.g. breakthrough ideas;
  • Language skills: fluent in Japanese (passed the top level test), native of Chinese, and business level in English.
Core Accomplishments

2013, Diplomate of the American Board of Toxicology

2010 – Present, Immunologist, work topics: consulting review and regulatory research; as a consulting reviewer provide expert opinions and recommendations into requested review documents from other reviewers, especially in products associated immunotoxicity in preclinical risk assessment, offer purpose-specific experimental protocols to help sponsor in addressing the safety concerns, and involved in the regulatory approval process. As a principal investigator also focus on non-animal based clinically relevant biomarker identification and development for preclinical risk assessment and clinical risk management; collaboration with academic in computational quantitative chemical structure-biological activity relationship in CDRH/FDA;

2011 Critical Path Initiative granted to identify and develop biomarkers for addressing regulatory specific safety concerns, medical device associated immunotoxicity and overcoming the limitations of animal based testing methods;

2008 – 2010, CDER/FDA, Pharmacology/Toxicology Reviewer, work topics: review the drugs/immunosuppressants included small molecules and monoclonal antibodies in renal transplantation and its risk management.

Professional Experience
ImmunologistMay 2010 to Current
U.S. FDA - Silver Spring, MD

Work topics: consulting review and regulatory research; as a consulting reviewer provide expert opinions and recommendations into requested review documents from other reviewers, especially in products associated immunotoxicity in preclinical risk assessment, offer purpose-specific experimental protocols to help sponsors in addressing the safety concerns, and involved in the regulatory approval process. As a principal investigator focus on non-animal based human biomarker identification and development for preclinical risk assessment and clinical risk management; collaboration with academic in computational quantitative chemical structure-biological activity relationship in CDRH/FDA;

•2011 Critical Path Initiative granted to identify and develop biomarkers for addressing regulatory specific safety concerns, medical device associated immunotoxicity and overcoming the limitation of animal based testing methods.

Pharmacology/Toxicology Reviewer Jun 2008 to May 2010
U.S. FDA - Silver Spring, MD

As a Pharmacology/Toxicology Reviewer, work topics: review the drugs/immunosuppressants included small molecules and monoclonal antibodies in renal transplantation and its risk management;

•Members of the Society of Toxicology (external); members of Biocompatibility Standards Technical Group.

Research Assistant ProfessorApr 2006 to Jun 2008
University of Pittsburgh - Pittsburgh, PA

Focused on clinical pharmacology, mechanistic and pharmacological based drug development

Principal InvestigatorApr 2003 to Mar 2006
University of Pittsburgh - Pittsburgh, PA

work topics: pharmacogenomics based cytochrome P450 regulation and chemical induced liver toxicity/Pharmacology and Toxicology, and new drug discovery and development, one new molecule entity was patented.

Post doctoral fellowAug 2002 to May 2003
University of Pittsburgh - Pittsburgh, PA

pharmacogenomics based cytochrome P450 regulation and chemical induced liver toxicity/Pharmacology and Toxicology

Pittsburgh Tissue Engineering Initiative Post doctoral fellowApr 2001 to Aug 2002
Carnegie Mellon University - Pittsburgh, PA

Stem cells induced bone tissue engineering

Japan Society for Promotion of Sciences Post doctoral FellowApr 1999 to Mar 2001
Kyoto University - Kyoto, Kyoto/Japan

metallic partials induced immunotoxicity in laboratory animals

Japan Science and Technology Corporation post doctoral fellowApr 1995 to Mar 1999
National Institute for Materials Science - Tsukuba, Ibaraki/Japan

Biomaterials/metallic and polymer partials induced immune reactions in laboratory animals and primary macrophages

Education
Ph.D., Medicine/physiology and pathology 1994Gunma University - Maebashi, Gunma, Japan
Bachelor of Science, Medicine1982Zhejiang University - Hangzhou, Zhejiang, China
Certifications

Continuing Education

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Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • U.S. FDA
  • University of Pittsburgh
  • Carnegie Mellon University
  • Kyoto University
  • National Institute for Materials Science

School Attended

  • Gunma University
  • Zhejiang University

Job Titles Held:

  • Immunologist
  • Pharmacology/Toxicology Reviewer
  • Research Assistant Professor
  • Principal Investigator
  • Post doctoral fellow
  • Pittsburgh Tissue Engineering Initiative Post doctoral fellow
  • Japan Society for Promotion of Sciences Post doctoral Fellow
  • Japan Science and Technology Corporation post doctoral fellow

Degrees

  • Ph.D. , Medicine/physiology and pathology 1994
    Bachelor of Science , Medicine 1982

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