Zoetis seeks to hire a Clinical Researcher, based in Lincoln, Nebraska.
Position Summary
Responsible for the clinical qualification and first time approval of references used in veterinary vaccine potency tests in compliance with the Reference Qualification program standards & procedures. Position will initiate and perform clinical model review including, but not limited to clinical study development and oversight, challenge preparation and qualification, and the preparation of pivotal reports. Will serve as Principle Investigator for clinical studies. In addition, individual may participate in meetings with USDA Policy, Evaluation, & Licensing (PEL) officials to influence USDA on technological advances and statistical evaluations.
Position Responsibilities
Study Management: Assist/Lead the coordination of all study activities, including start up, investigator training, conduct, site monitoring and close out. These may include, but are not limited to:
- Assist/Lead the design and implementation of livestock and companion animal studies to demonstrate efficacy; refining models and endpoints.
- Assist/Prepare study and animal use protocols, data capture forms, test article documentation
- Perform data management process including data capture, entry, review, tracking and verification
- Assist/Responsible for interpretation of clinical results
- Assist/Prepare study reports
- Assist with regulatory submissions
- Maintain study files in accordance with SOPs and regulatory requirements
- Establish contacts with external experts and third party contractors for the conduct of clinical studies.
- Source, place and execute studies internally and externally with contract research organizations. Serve as the principal communication link between sponsor and study site.
- Initiate required legal and financial documents for research activities
- Participate/Perform animal related study activities (i.e. clinical sampling, test article administration, and clinical observations)
Project Team: Incumbent will participate in/lead multiple project teams with the following duties and responsibilities:
- Interactions with multiple groups including Institutional Animal Care and Use Committee, Manufacturing, Regulatory Affairs, Technical Support, Quality Control, Research and Development, Quality Assurance
- Facilitate/document team meetings
- Assist/Manage project resources including budget and timelines
- Assist/Lead internal change control
- Candidate may serve as an IACUC member and/or as back-up to the site Attending Veterinarian.
Education and Experience
Educational Background
Minimum: Doctor of Veterinary Medicine with a minimum of 2 years of clinical or industry experience.
Desirable: DVM with an advanced degree (MS, PhD, Board Certified) and with post-graduate training in clinical veterinary medicine or in a scientific discipline relevant to animal disease and clinical study design. Minimum 5 years clinical or industry experience.
Work Experience
Minimum: Demonstration of organizational and interpersonal skills as well as written and oral communication.
Desirable: A good understanding of livestock and companion animal disease pathogenesis, husbandry and production medicine. Experience and interest in working with livestock including cattle (dairy/beef), swine and/or poultry, as well as companion animals, which may include horses. Previous experience in a research environment (GCP/GLP) and/or previous experience in research/product development in the animal health industry. Experience as a project leader for biological product research.
Technical Skills and Competencies
- Demonstration of initiative, independent thinking, strong organizational and interpersonal skills, and detail orientated.
- Competence in Microsoft Word, Excel, Powerpoint.
Physical Position Requirements
- This position works in animal research facilities handling a variety of livestock and companion animals. There may be exposure to animal wastes, chemicals and biologics. Work will be conducted in office, lab, clinic, bio-containment and animal housing facilities. There may be exposure to temperature, climate extremes and dirty and dusty conditions.
- Flexible work hours, including holidays may be required.
- Lifting up to 50 pounds.
- Travel: approximately 10 – 20% on an annual basis. Variable, depending upon project status.
To Apply
To apply, click here or go to www.zoetis.com/careers and search US Jobs for JR00002842.
Direct questions to Malissa Sittler, Human Resources Manager, Zoetis Lincoln Operations: 402-441-2182 or malissa.sittler@zoetis.com.