IND-Enabling & Clinical Trials Core Technical Director
University of Chicago
Department
BSD ARC-SRF - Animal Resource Center & Office of Shared Research Facilities
About the Department
Job Summary
The Technical Director leads the design and execution of IND-enabling studies, including both Good Laboratory Practice (GLP) and non-GLP animal studies, ensuring adherence to regulatory standards and quality assurance requirements. This position serves as the primary point of contact for external partners, facilitating collaboration and connecting stakeholders to University resources, including contracting and shared research services.
In addition, the Technical Director is responsible for advancing the visibility, utilization, and growth of the Core by strengthening internal partnerships and expanding external engagement.
Responsibilities
Oversee overall Core operations, services, and performance, ensuring efficient and high-quality service delivery.
Recruit, train, and supervise technical staff, including ongoing development and performance management.
Lead and maintain the quality assurance (QA) program, ensuring adherence to all regulatory and institutional standards.
Manage budget, billing, and fee-for-service structures, including development and oversight of chargeback models.
Develop, track, and report key performance indicators (KPIs) and operational metrics to leadership, including UCCCC and BSD.
Serve as the primary point of contact (POC) for external partners, facilitating access to University resources and coordinating contracting processes.
Identify, select, and manage vendors for outsourced assays and services, including clinical pathology, histopathology, and other specialized needs.
Design, manage, and oversee execution of IND-enabling GLP and non-GLP animal studies.
Collaborate with investigators to develop study protocols, SOPs, forms, study reports, and overall study design.
Develop study timelines and calendars, and coordinate cross-functional teams, including IND-Enabling & Clinical Trials Core staff, Animal Resources Center (ARC) staff (SSP specialists, SSP supervisor, veterinary technicians, attending veterinarian), GLP personnel, and investigator teams.
Ensure regulatory compliance and quality standards across all study activities and Core operations.
Oversee procurement, ordering of supplies, inventory management, and expense tracking.
Serve as document control lead and archivist, ensuring proper maintenance and organization of study records.
Coordinate sample logistics and reporting with external vendors, including shipment, tracking, and receipt of study data and reports.
Provides expertise to researchers on compliance of research activities with institutional, state, and federal regulatory policies, procedures, directives and mandates.
Provides expertise to researchers and research support staff. Oversees activities related to data collection and analysis.
Leads the establishment of new laboratories and provides assistance with purchasing new laboratory equipment; ensuring efficient operation of laboratory, including overseeing maintenance and repair of laboratory equipment.
Improves financial, personnel, planning, compliance and other administrative aspects of research project. Collaborates with other researchers on long-range plans for research projects. Leads, investigates, modifies and applies new procedures, techniques or applications of technology. Establishes goals and operating procedures, practices, and guidelines.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Advanced College or university degree in related field strongly preferred.
Experience:
Prior experience in regulatory writing and Good Laboratory Practice (GLP) studies.
Licenses and Certifications:
Project Management & Certified Manager of Animal Resources certifications strongly preferred.
Preferred Competencies
Demonstrated record of research achievement.
Work independently and manage multiple projects simultaneously.
Excellent organizational skills and attention to detail.
Strong problem-solving and analytical skills.
Advanced knowledge in relevant field of research.
Advanced knowledge of research techniques and/or methods.
Excellent verbal and written communication skills.
Working Conditions
Office and wet lab environment.
Extended periods sitting at computer and walking to facilities.
Application Documents
Resume (required)
Cover Letter (preferred)
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Family
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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