Immunologist Resume Example

•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.

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.

Continuing Education