Summary
Overview
Work History
Education
Skills
Publications
Training
Other notable experience
Awards
Timeline
Generic

Dominique Nguyen

Irvine,CA

Summary

A highly motivated regulatory scientist with a keen interest in research compliance seeking opportunities in clinical trials compliance and management of new devices,

Overview

19
19
years of professional experience

Work History

Regulatory Scientist

23andMe, Inc.
Sunnyvale, CA
06.2021 - Current
  • Develop and manage multiple IRB-approved study protocols for human subject research studies
  • Negotiate with the IRB
  • Independently conduct complex reviews, auditing, and monitoring related to research noncompliance, conflict of interest, Responsible Conduct of Research, relevant training requirements, and other targeted research compliance-related areas.
  • Carefully review all research-related materials for adherence to research compliance laws and regulations and align with best practices.
  • Work with researchers to correct and implement remediation for noncompliance.
  • Interpret regulatory rules or rule changes and communicate with others through company policies and procedures.
  • Performed complex troubleshooting and led initiatives to solve challenging regulatory challenges
  • Assign required training of employees based on their roles and audit training program for the Research team
  • Create guidance material and documentation.
  • Team lead for standard operating procedures management and training
  • Assign new employees with training
  • Managed several simultaneous complex projects, meeting all important milestones.
  • Developed and maintained relationships with key stakeholders
  • Cross functionality and stakeholder alignment
  • Trained new employees in areas of regulatory and compliance
  • Recruited and hired top performers to add talent and value to the team.

IRB Chair

Stanbridge University
Irvine, CA
02.2020 - 06.2021
  • Served as the regulatory and technical expert for all IRB matters
  • Developed and implemented IRB policies and procedures.
  • Developed a comprehensive in-house online IRB resource for Stanbridge’s research community
  • Oversaw IRB compliance for institutional-wide research that included monitoring research activities and IRB audits
  • Performed IRB-directed reviews such as exempt determinations and expedited reviews.
  • Provided ongoing training of investigators, IRB members, and students on issues that are relevant to the protection of human subjects
  • Prepared, reviewed, and maintained IRB documentation
  • Reviewed all IRB applications to assess research question, research, design and methodology, data analyses, and ethics
  • IRB Administration: Established IRB Policies and Standard Operating Procedures, designed a battery of new forms to improve the IRB Review Process, established a diverse expert IRB committee
  • Chaired shareholder meetings, disseminated information, and fielded questions.
  • Contributed to the values, goals, and strategic vision of the organization.
  • Planned and oversaw meetings per governing documents.
  • Facilitated decision-making by building consensus and developing solutions.
  • Composed and transcribed well-written reports, emails, and technical documents.
  • Completed CITI Training Programs for Institutional Signatory Official, IRB Administrator IRB Chair, IRB Review Board, and Social and Behavioral Research
  • Cross-functional work: collaborative work with other faculty and departments to develop a thesis support office and different ways to enhance the research experience
  • Provided ongoing research guidance to support graduate students through in-depth literature and thesis reviews, one-on-one mentoring
  • Research design consultations for faculty and students.
  • Developed a graduate research course on research methods and quantitative e methods with SPSS workshops and experimental design for a Master’s of Occupational Therapy Program
  • Developed a graduate research methods course for a Master’s of Nursing Program
  • Instrumental in the design of graduate thesis programs
  • Spearheaded the development of an Office of Graduate Research to promote scholarship and research
  • Supported WASC accreditation on process
  • IACUC committee member

Private Tutor

Self Employed
Phoenix, AZ
01.2011 - 01.2018
  • Delivered comprehensive private tutoring services to high school students in academic environments
  • Instructed various subjects including world history, biology, algebra, and chemistry.
  • Used positive reinforcement, repetition and review to help students master challenging material.
  • Conducted group tutoring sessions to help students engage active learning and critical thinking skills.
  • Planned and facilitated tutoring workshops for student groups on subjects of interest.
  • Tracked learning progress to optimize tutoring methods and help students achieve goals.

Chief Scientific Officer

Phoenix Cancer Support Network
Phoenix, AZ
01.2016 - 11.2017
  • Initiated a new non-profit business by delivering wide-ranging support for cancer care and advocacy while communicating with other non-profit organizations to improve business performance
  • Provided expert review on customer-facing scientific material
  • Fundraising, grant writing, community outreach, and education
  • Served as an original board member and helped grow the organization

Business Owner/Operator

Oncoguard
Irvine, CA
01.2009 - 11.2011
  • Established the company from the ground up, directing all aspects of the business including sales, business development, contract negotiations
  • Leveraged solid market knowledge in developing and advertising nutraceuticals with a mission to promote good health.
  • Negotiated with suppliers according to forecasted customer demand.
  • Analyzed and tracked business metrics and made appropriate adjustments to meet supply and demand needs.
  • Established foundational processes for business operations.

Homemaker/Volunteer Teacher

Private
Westfield, NJ
01.2006 - 01.2009
  • Took a career break to raise children; stayed active in the community through volunteer teaching and STEM mentorship to young students
  • Managed rentals and built a vacation rental business

Postdoctoral Research Scientist

University Of Hawaii Cancer Research Center
Honolulu, HI
09.2005 - 01.2006
  • Tested the efficacy of novel lipid-soluble carotenoids, leveraging cell biology and immunohistochemical expertise in the prevention of prostate cancer while collaboration with Hawaii Biotech.
  • Upheld all university and regulatory requirements for documentation of findings.
  • Maintained records of research findings with analysis and evaluation of results.
  • Completed analysis of data acquired from research and verified careful documentation of information.
  • Attended research seminars and collegiate meetings to discover and discuss new technologies and research.

Scientist

Hawaii Biotech
Aiea, Hawaii
08.2003 - 09.2005
  • Complex research design and execution.
  • Performed complex troubleshooting and led initiatives to solve challenging scientific problems with assay development for preclinical drug development
  • Conducted moderately complex analysis of in vitro ADMET pharmacokinetics of small molecule drugs.
  • Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
  • Recognized as an integral member of the medicinal chemistry and biology team, delivered cell biology and pharmacology expertise in the identification of new drug targets that fit project agendas
  • Cultivated strong rapport with external and offsite collaborators at NIH to ensure program success and alignment.
  • Executed grant writing for a number of company government grants (SBIR).

Education

Bachelor of Science - Physiology, Pharmacology & Toxicology

Monash University
Melboure, Australia

Bachelor of Science (Honors) - Medicine

University of Melbourne
Melbourne, Australia

Ph.D. - Molecular Pharmacology & Toxicology

University of Southern California
Los Angeles, CA

Skills

  • Regulatory Scientist with a unique background in preclinical development and academia
  • Compliance
  • Knowledge of FDA regulations that govern the conduct of clinical trials
  • Experience with management of consent hierarchy, governance, and secondary uses of data
  • Knowledge of privacy matters, data access, and control requirements
  • Familiarity with Privacy matters
  • Crossfunctionality, relationship building, and stakeholder alignment
  • Strong interpersonal skills
  • Technical knowledge: JIRA, Learning Management Systems Veeva Vault, AWS Quicksight, SPSS, Statview, Google suite, Microsoft Word and Excel

Publications

Publications

  • Youssef S., Nguyen D.T., Soulis T., Panagiotopoulos S., Jerums G., and Cooper M.E. Effect of diabetes and aminoguanidine therapy on renal advanced glycation end product binding. Kidney International, 55, 907-16, 1999.
  • Nguyen D.T., Hernandez E., Vauzour D., Schonthal A.H., Rice-Evans C., Cadenas E. and Spencer J.P.E. The intracellular genistein metabolite 5,7,3¢,4¢-tetrahydroxyisoflavone mediates G2-M cell cycle arrest in breast cancer cells via modulation of p38 signaling pathway Free Rad Biol & Med 15;41, 2006.:1225-39
  • Goldman M.E., Cregar L., Nguyen D.T., Simo O., O’Malley S. and Humphreys T. Cationic polyamines inhibit anthrax lethal factor protease BMC Pharmacology 6:8, 2006

Abstracts

  • Spencer J.P.E, Nguyen D.T., and Vasour D. Flavanoid regulation of cell cycle via interactions of MAP kinase and PI3 kinase/AKT kinase Oxidants and antioxidants in biology, Oxygen Club of California, 2006
  • Goldman M., Cregar L., Nguyen D.T., Simo O., O’Malley S., Nagata M., Jiao G., Tang C. Discovery and characterization of nucleic acid-independent cationic inhibitors of anthrax lethal factor protease. Biomolecular Screening 2004
  • Tang C., Simo O., Nagata M., Jiao G., O’Malley S., Goldman M., Cregar L., Nguyen D. and Hemscheidt Design, synthesis, and SAR of anthrax lethal factor protease inhibitor A261 Proceedings from the American Chemical Society, 2004
  • Nguyen D.T., Garcia J.V., and Cadenas E. Genistein causes cell cycle arrest and apoptosis in T47D breast cancer cells. Oxidants and antioxidants in biology, Oxygen Club of California, 2002.
  • Nguyen D.T., Garcia J.V., and Cadenas E. Genistein causes cell cycle arrest in T47D breast cancer cells. Free Radical Biology & Medicine, 2001
  • Nguyen D.T., Garcia J.V., and Cadenas E. Genistein causes cell cycle arrest via inhibiton of p53-independent mechanisms in T47D breast cancer cells. Free Radical Biology and Medicine, 2000.
  • Nguyen D.T., Sastra S., Panagiotopoulos S., Soulis T., Cooper M.E., and Jerums G. Parallel increases in fluorescent and immunoreactive advanced glycation end products in early diabetes. Australian Diabetes Society Proceedings, 1996.
  • Nguyen D.T., Panagiotopoulos S., Soulis T., Cooper M.E., and Jerums G. Aminoguanidine and methylguanidine reduce mesenteric vascular enlargement in experimental diabetes. Diabetologia 38 Supplement I, A255, 1995.
  • Sastra S., Soulis T., Panagiotopoulos S., Nguyen D.T., Cooper M.E., and Jerums G. Development of polyclonal antibody based elisa for advanced glycation end products. Australian Diabetes Society Proceedings, A89, 120, 1995.
  • Nguyen D.T., Sastra S., Panagiotopoulos S., Soulis T., Cooper M.E., and Jerums G. Parallel increases in fluorescent and immunoreactive advanced glycation end products in early diabetes. Australian Diabetes Society Proceedings, 1996

Training

  • CITI training completed for ICH/GCP E6(r2) [Transcelerate Biopharma approved training]
  • CITI Human Subjects Research, and IRB Chair & Administrator, Social & Behavioral Research
  • Leadership development training (in progress)
  • IACUC AALAS training
  • Certified IRB Professional (CIP) eligible


Other notable experience

  • 2000-2003: Research and teaching assistant at the University of Southern California
  • 1998-2000: Research assistant at the University of Texas at Austin
  • 1997-1998: Research assistant at Texas A&M Medical School
  • 1995-1997: Research and teaching assistant at the University of Melbourne


Awards

2000: Young Investigator’s Award, Oxygen Society, San Diego, California, USA

1998: College of Pharmacy Travel Grant, the University of Texas at Austin

1996: Australian Diabetes Travel Award

1996: European Association for the Study of Diabetes Award

1996: National Heart Foundation Young Investigator's Travel Award

1996: Australian Juvenile Diabetes Foundation Travel Award

1994-1996: Australian Postgraduate Award

Timeline

Regulatory Scientist

23andMe, Inc.
06.2021 - Current

IRB Chair

Stanbridge University
02.2020 - 06.2021

Chief Scientific Officer

Phoenix Cancer Support Network
01.2016 - 11.2017

Private Tutor

Self Employed
01.2011 - 01.2018

Business Owner/Operator

Oncoguard
01.2009 - 11.2011

Homemaker/Volunteer Teacher

Private
01.2006 - 01.2009

Postdoctoral Research Scientist

University Of Hawaii Cancer Research Center
09.2005 - 01.2006

Scientist

Hawaii Biotech
08.2003 - 09.2005

Bachelor of Science - Physiology, Pharmacology & Toxicology

Monash University

Bachelor of Science (Honors) - Medicine

University of Melbourne

Ph.D. - Molecular Pharmacology & Toxicology

University of Southern California
Dominique Nguyen