Associate Director, Nonclinical Function Lead and CPEC Chair

• Mar 2022 - Present

Senior Manager and Nonclincial Function Lead

• Jul 2021 - Mar 2022

Project Manager and Regulatory Writing

• Oct 2020 - Jun 2021

- Lead regulatory activities and manage project implementation for IND submission as a project leader;- Prepare CTD dossier in registration of new drug products;- Provide consulting service to different pharmaceutical companies for safety assessment of new drug products.

Postdoctoral Fellow

• Sep 2015 - Aug 2021

- Working on Pharmacogenomics assessment of idiosyncratic drug-induced liver toxicity (DILI) in Diversity Outbred (DO)mice; - Discovering and evaluating novel microRNA biomarkers to predict nephrotoxicity in human; - Conducting dose-response analysis of drug-induced toxicity to support the risk assessment. - Working on Pharmacogenomics assessment of idiosyncratic drug-induced liver toxicity (DILI) in Diversity Outbred (DO)mice; - Discovering and evaluating novel microRNA biomarkers to predict nephrotoxicity in human; - Conducting dose-response analysis of drug-induced toxicity to support the risk assessment.

Visiting Scientist

• Apr 2015 - Sep 2015

- Developed and optimized novel methods to detect toxicity and inflammatory effect induced whole cigarette smoke and tobacco products in 3D human tissue cultures;- Discovered novel biomarkers associated with human pulmonary toxicity and lung cancer in in vitro 3D human lung tissue model;- Investigated the molecular mechanism of toxicity induced by tobacco products;- Provided the support for regulatory decision-making process and risk assessment.

ORISE/ISEP Fellow

• Sep 2011 - Mar 2015

- Designed, performed, analyzed and reported the genetic toxicity studies;- Evaluated FDA regulatory products and provided scientific and regulatory support in risk assessment;- Developed and optimized a novel flow cytometry-based mutation detection in an autosomal and X-linked gene of mice heterozygous for endogenous CD24 gene;- Assessed genotoxicity of dietary supplements, nanomaterials and informed the potential mechanism;- Developed new biomarkers to differentiate the toxicities produced by different tobacco smoke in human airway tissue models;- Trained in regulatory toxicology and risk assessment through the regulatory science program sponsored by FDA and Arkansas University for Medical Sciences (UAMS). Show less

Study Director/ Head of Department of Genetic and Reproductive Toxicology

• Jul 2008 - Sep 2011

Department Head: - Oversaw the Tox. Studies in compliance with 21 CFR Part 58, OECD & CFDA GLP; - Served as a Tox. expert to communicated with clients in the early stage of drug discovery and development; - Led the team to timely complete the client projects; - Communicated with clients and interacted with regulatory authorities to discuss scientific and regulatory affairs as a certified Toxicologist; - Contributed to validation of new regulatory assays and novel methods; - Participated in scientific and regulatory activities as a expert; - Coordinated the Genetic and DART projects inter- and intra- departments and research teams to ensure that the client projects are effectively managed; - Served as a project manager to arrange the projects and assign to Study Directors; - Provided the technical and scientific support to Study Directors. Study Director: - Designed the studies, prepared protocols, analyzed and interpreted data, and reported the studies; - Ensured the studies in compliance with 21 CFR part 58, OECD GLP and CFDA GLP as a single point of control on the assigned studies; - Familiarized the regulatory guidance s and requirements on preclinical studies; - Trained the research technicians to strictly follow SOPs ; - Contributed to SOPs update and maintenance. Show less