Tam Nguyen
Senior Manager, Clinical Scientist @AbbVie
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WORK HISTORY
Senior Manager, Clinical Scientist @AbbVie
Irvine, CA, US
Leading protocol designs and implementations of clinical development strategy to support overall asset development plan with medical and scientific considerations as well as compliance and regulatory requirements• Leading and acting as champions in innovations and process improvements such as medical monitoring plan, NEXUS• Leading discussions with principal investigators on current clinical trials and leading outreach efforts to KOLs to discuss future directions• Acting as or supporting Therapeutic Area Scientific Director in the execution of the clinical development plan, regulatory submissions, and development of associated clinical trial documents (e.g, clinical protocols, amendments, investigator brochures, procedure manuals, informed consent forms, training materials, eCRF, and clinical study reports)• Leading clinical study teams, monitoring overall study integrity, reviewing interpretation and communication of data pertaining to safety and effectiveness of the asset• Performing ad-hoc/Clinical Development internal analyses of study data to assist with leadership review and risk monitoring effort in collaboration with CSL and Monitoring• Serving as an in-house clinical expert for assets in the therapeutic area, coordinating and leading scientific and medical activities with internal stakeholders including Medical Affairs, Regulatory Affair, Clinical Operations, Statistics and Programming, Data Management, etc. • Leading manuscripts, abstracts, and presentation publication effort for approved assets• Leading and supporting global Regulatory Agency responses with clinical expertise for current assets• Leading and supporting the development of innovative pipeline products from clinical perspective• Ensuring adherence to Good Clinical Practices, Clinica Development SOPs, and all AbbVie standard in conducting research
EDUCATION
University of Minnesota College of Pharmacy
Doctor of Pharmacy (Pharm.D.), Pharmaceutical Sciences
University of Minnesota
Bachelor of Science (B.S.), Genetics, Cells biology, and Development
ABOUT TAM NGUYEN
I\'m currently a Senior Clinical Scientist at AbbVie. I have experiences working in multiple global, multicenter, double-blinded, randomized trials in Clinical Development. My main responsibilities include protocol development, endpoint decisions, manuscripts/CSR/submission document writing, data review, and cross-functional communication. I have a great passion for Clinical Scientist and want to continue on this path for the next 5-10 years.I received my Doctor of Pharmacy Degree in 2021 and a Bachelor of Science in Genetics, Cells Biology, and Development in 2017 at the University of Minnesota, Twin Cities. During my undergraduate years, I was working primarily with Hunter Syndrome (MPS II) and different gene therapies using mouse models under Dr. R. Scott McIvor at the University of Minnesota - Twin Cities, Medical School. I continued my passion for genetics in Pharmacy School by involving in translational pharmacogenomics research at the University of Minnesota Medical Center - Fairview Hospital.
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