Overview As Regulatory Scientist II you will serve as the Study Director under FDA GLP rules, overseeing scientific, technical and regulatory aspects of regulated nonclinical studies. You collaborate with the ORNcS, sponsors, and funding agencies to design and execute GLP-compliant work and may lead extramural programs as PI. You balance research innovation with regulatory compliance, reporting, and interpretation of results. This role offers the chance to shape regulated research programs and contribute to health outcomes at UTMB.
Responsibilities- Act as Study Director with overall control of regulated nonclinical studies under GLP.
- Design and execute studies in cooperation with sponsors and the ORNcS.
- Interpret, document and report study results; prepare manuscripts for peer-reviewed journals.
- Train and supervise research staff and fellows; ensure adherence to internal controls.
- Manage projects with minimal supervision; contribute to protocol development and optimization.
- Perform data analysis including big data analytics, data mining, and visualization.
- Apply bioinformatics tools and databases; conduct theoretical and methodological development.
Key requirements- Ph.D. and/or MD, DVM
- 1-3 years of experience conducting regulated studies
- 7+ years of experience in infectious diseases research with viral or bacterial pathogens (including animal studies)
- Good Laboratory Practice training
- BSL3 and/or BSL4 laboratory training
- Experience with qualitative data collection and analysis including mixed methods
- Ability to obtain clearance for work with Tier 1 Select Agents and be registered as a PI under FSAP
- strong communication skills
- ability to work with cross-functional teams
- problem solving and creativity
- Big data analytics
- Data engineering
- Statistical analysis
