Preclinical Study Director I

Company Description IBEX Preclinical Research is a trusted partner in preclinical medical device research, backed by over 20 years of experience. The organization is an AAALAC accredited, GLP compliant facility known for its commitment to quality, integrity, and scientific rigor. IBEX specializes in preclinical testing across orthopedics, wound care, ophthalmology, cardiovascular, gastrointestinal, and implant toxicity, providing comprehensive evaluation of device safety and performance. The team also conducts non-surgical studies, including nonsurgical drug toxicity and pharmacokinetic studies, supported by experienced veterinary surgeons and research associates who ensure high-quality execution of every study.

Role Description The Preclinical Study Director is a full-time, on-site role based in Logan, UT. This individual oversees the design, planning, and execution of preclinical studies for medical devices and related products, ensuring compliance with GLP standards and institutional policies. Day-to-day responsibilities include developing study protocols, coordinating laboratory and in vivo activities, and monitoring study progress and data integrity, study report writing. The role involves close collaboration with veterinary surgeons, research associates, and sponsor representatives, quality assurance. The Study Director is also accountable for project timelines.

Qualifications

• Strong laboratory skills, including familiarity with preclinical testing methods and adherence to GLP practices.
• Demonstrated research experience in preclinical or biomedical fields, with the ability to design and interpret complex studies.
• Experience with in vivo models and study oversight, ensuring ethical and compliant animal care and use.
• Project management skills, including planning, coordinating cross-functional teams, and managing timelines and budgets.
• Effective written and verbal communication skills, with the ability to prepare clear reports and interact with sponsors and regulatory stakeholders.
• Master’s Degree or equivalent in a related discipline required
• 5 years of experience in a GLP-compliant laboratory preferred
• Experience with peer reviewed publications, presentations, scientific writing
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications
• Good written and oral communication skills
• Knowledge of GLPs (FDA) and other federal regulations relating to care of laboratory animals
• Strong understanding of study design and protocols
• Strong understanding of laboratory operations and data collection
• Ability to work under specific time constraints

Primary Responsibilities and Competencies:

**Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Team Study Support:

• Provide support to protocol development, amendments, and deviation writing, and contribute to the preparation of study draft reports by performing accurate data entry, cross-checking source data, and verifying data integrity in compliance with study protocols and institutional SOPs.
• Provide support to the development, revision, and pre-QA review of study worksheets, ensuring data accuracy, protocol alignment, and readiness for Quality Assurance (QA) final review.
• Order special supplies or products that are study specific.

For Assigned Studies:

• Represent the single point of control for all aspects of a study while serving as Study Director for non-clinical studies.
• Responsible for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure that the protocol, including any changes/amendments, are approved and followed.
• Ensure all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
• Ensure that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
• Ensure that Test systems are as specified in the protocol.
• Ensure compliance with protocol, amendments, regulatory agencies as identified in the protocol, and SOPs.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of a study.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.