Regulatory Scientist I / II - Institutional Office of Regulated Nonclinical Studies (ORNcs)

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 I / 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:

• Responsible for the overall planning, conduct and reporting of non-clinical regulated studies, in accordance with applicable regulations and regulatory guidance, contemporary scientific practice and sponsor requirements. 
  
• Produce study protocols and reports to meet client and regulatory requirements while demonstrating knowledge of requirements and plans accordingly regarding timelines, critical deadlines, etc.
  
• May be required to develop and/or implement an array of research methods to support each study’s needs; may collaborate with and/or lead research teams and oversee the direction of projects.
  
• Supervise a scientific team to conduct regulated studies and ensure the study is performed in accordance with all applicable regulations, requirements of an applicable quality agreement, the study protocol, and standard operating procedures.
  
• Provide internal and external communications, scientific expertise, and regulatory compliance expertise; able to interact and communicate with individuals across the organization at all levels of university, government and commercial sponsors and share knowledge with colleagues in other disciplines.
  
• Demonstrate the ability to execute multiple, complex, multi-disciplinary technical projects.
  
• Adheres to internal controls and reporting structure.
  
• Performs related duties as assigned.
  May participate in UTMB educational or professional development activities as lecturer or facilitator with agreement of the ORNcS Scientific
• Director and relevant course/program directors.
  

KNOWLEDGE/SKILLS/ABILITIES:

• Strong quantitative analytical skills with evaluation methods and design experience.
  
• Strong project management skills and superior written and verbal communication and interpersonal skills.
  
• Knowledge of and ability to interpret regulatory requirements and perform duties in compliance with those requirements.
  
• Ability to lead a scientific team, effectively mentor others and exhibit strong leadership abilities.
  
• Ability to work well with a wider team of technical, quality control, quality assurance and administrative personnel, and in collaboration with other investigators as appropriate to the requirements of a study and the operations of the ORNcS.
  

EDUCATION & EXPERIENCE

MINIMUM QUALIFICATIONS:

•  Ph.D. and/or MD, DVM.
•  1 - 3 years of experience conducting regulated studies.
•  5+ 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).

PREFERRED QUALIFICATIONS:

• Ph.D. in microbiology, immunology, pathology, or similar discipline, and/or MD or DVM.
  
• 5+ years of experience working with infectious disease research with viral or bacterial infections of small animal and/or nonhuman primate models of human infectious diseases at BSL3 or higher levels of biocontainment.
  
• Previously served as a Study Director on regulated studies, preferably for FDA Animal Rule studies.
  
• Prior registration with the US FSAP and experience working with select agents.
  

SUPERVISION
Received: Scientific Director, ORNcS
Given: May be responsible for direct supervision of and will provide oversight for Regulatory Scientists, Research Scientists, Research Associates, Research Technicians working with the ORNcS.  Will provide oversight for veterinary technicians and other research staff involved in conduct of regulated studies.

BUDGET RESPONSIBILITY 
Direct: Will be responsible for fiscal oversight of extramurally funded projects for which they serve as Principal Investigator.
Indirect: May assist the ORNcS Scientific Director with institutional budget planning.

DECISION-MAKING RESPONSIBILITY 
Project management decisions to ensure proper conduct of a regulated study.

WORKING ENVIRONMENT/EQUIPMENT:

• MS Office and Microsoft Project.
  
• Biostatistical software applications, e.g. Graphpad Prism, SAS
  
• Standard Office Equipment.
  
• Electronic Document Management System (Master Control).
  
• Laboratory equipment required for testing and analysis as appropriate.
  
• Working Environment/Location of Position:
  
• Standard office environment located on UTMB’s main campus and BSL2/BSL3/BSL4 laboratory environments, as appropriate.  Travel may be required as related to studies, training, and collaboration.  Must be willing to enter high-containment areas 
  

OTHER:

• Must be able to meet the medical and/or vaccination requirements for work in biocontainment facilities and with Tier 1 select agents.
• Individuals holding this title will also be required to hold a secondary non-tenure track faculty appointment in a UTMB basic sciences department and will participate in annual appointments/promotion/tenure reviews with that department.
  

SALARY:
Commensurate with experience 

Official Regulatory Statement for Healthcare jobs’ Job Descriptions: May be exposed to such occupational hazards as communicable diseases, blood borne pathogens, ionizing & non-ionizing radiation, hazardous medications and disoriented or combative patients or others.