MINIMUM QUALIFICATIONS:
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 method approaches. Able to obtain clearance for work with Tier 1 Select Agents and be registered as a Principal Investigator under the US Federal Select Agent Program (FSAP).
JOB SUMMARY
Function:
The Regulatory Scientist II will be assigned as a Study Director, as defined by the U.S. FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point of study control with overall responsibility for the scientific, technical and regulatory conduct of studies as well as for the interpretation, documentation and reporting of results. The Regulatory Scientist II works in conjunction with the Scientific Director for the Institutional Office of Regulated Nonclinical Studies (ORNcS), study sponsors and/or funding agencies to design and execute regulated nonclinical studies compliant with the U.S. FDA GLP regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory Scientist II may also function as a Principal Investigator for extramurally funded research programs and be expected to manage complex programs with multiple studies.
ESSENTIAL JOB FUNCTIONS:
Conduct innovative scientific investigations by developing theories and devising scientific methods and procedures to apply scientific principles, theories, and research in projects related to the mission of UTMB. Participate in the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care for the citizens of Texas. Manage computational laboratory operations, including staff development and adherence to applicable policies, laws, and regulations. Establishes research objectives and methodology, designs procedures, conducts research projects, analyzes, and interprets results. Preparation and publication of manuscripts in peer review journals. Ensures proper training of Research staff, Pre and Post-Doctoral Fellows. Adheres to internal controls and reporting structure Algorithm development and performance optimization Big data analytics Data engineering Statistical analysis Data visualization Data mining and machine learning Network analysis Ability to manage research projects with minimal supervision Bioinformatics tools and databases Writing and presentation skills Problem solving and creativityUSEFUL SKILLS/EXPERIENCE WITH: Cell culture Molecular biologySALARY:Commensurate with experience Equal Employment OpportunityUTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Compensation
