Chief Scientist, Director, Clinical Research Lab

BBSS Beyond Blue; Chandler (AZ); Vor Ort; USD 200.000 - 260.000; Vollzeit

Zusammenfassung

Beyond Blue Corporation seeks a Chief Scientist/Director to establish and lead a CLIA-certified Clinical Research Laboratory. The role includes strategic oversight of laboratory operations, regulatory compliance, quality systems, and assay development to support translational science and collaborations with UK HealthCare and industry partners.

The position requires a doctorate (MD/DO or PhD) with extensive leadership in clinical laboratory settings, and a proven track record in regulatory

Qualifikationen

• Must hold a medical doctor degree or doctoral degree in a clinical laboratory-related field.
• Experience leading clinical laboratory operations, regulatory compliance, and quality systems.
• Experience serving as a CLIA Laboratory Director or equivalent leadership role.

Aufgaben

• Provide scientific, clinical, operational, and regulatory leadership for the Clinical Research Laboratory.
• Direct laboratory operations, strategic planning, budgeting, staffing, and performance management.
• Align services with institutional research priorities and sponsor needs.
• Build and operate a CLIA-certified laboratory supporting validated testing and data management.
• Act as the CLIA Laboratory Director and ensure compliance with applicable regulations.
• Oversee QA/QC, proficiency testing, CAPA, audits, and inspection readiness.
• Lead assay development, validation, and ongoing performance monitoring.
• Collaborate with researchers and industry partners to translate new technologies into regulated testing.

Kenntnisse

Scientific leadership

Regulatory compliance

CLIA Director

Quality systems

Ausbildung

MD/DO or PhD in related field

Tools

LIMS

Jobbeschreibung

Beyond Blue Job Posting Title: Chief Scientist, Director, Clinical Research Lab Requisition Number: R-000005595 Department Name: Blue Shared Services Admin Work Location: UK Chandler Hospital, Pavilion H Grade Level: 25 Type of Position: Regular Position Time Status: Full time Equivalency Link https://hr.uky.edu/employment/working-uk/equivalencies Shift: Day (United States of America)

Job Summary

Responsible for establishing, leading, and directing the University's Clinical Research Laboratory as a shared, regulated research infrastructure supporting UK Research, UK HealthCare, the Advancing Kentucky Together Network, faculty investigators, and external clients. Serves as the scientific, clinical, operational, and regulatory leader of the laboratory and functions as the designated CLIA Laboratory Director. Provides strategic oversight for laboratory operations, scientific services, assay development, quality systems, accreditation, regulatory compliance, technology implementation, business development, and personnel management. Leads the development of a purpose-built clinical research laboratory supporting specialty testing services, including immunology, cellular analysis, flow cytometry, molecular diagnostics, bioanalytical testing, and other specialized laboratory methodologies. Collaborates with the Office of the Vice President for Research, Department of Pathology and Laboratory Medicine, UK HealthCare leadership, faculty investigators, industry sponsors, and external partners to advance research productivity, translational science, clinical trials, laboratory innovation, and economic development initiatives.

Essential Functions

• Provides scientific, clinical, operational, and administrative leadership for the Clinical Research Laboratory.
• Establishes and directs laboratory operations, strategic planning, budgeting, staffing, service development, and performance management activities.
• Collaborates with the Vice President for Research and the Chair of Pathology and Laboratory Medicine to align laboratory services with institutional research, clinical, and economic development priorities.
• Builds and operates a CLIA-certified clinical research laboratory supporting validated testing, quality systems, data management, and client service delivery.
• Serves as the designated CLIA Laboratory Director and fulfills all responsibilities required under applicable federal regulations.
• Establishes and oversees laboratory policies, procedures, operational standards, and performance expectations.
• Ensures laboratory readiness for growth, sustainability, and future expansion of testing capabilities.
• Provides scientific leadership for laboratory-developed tests (LDTs), research-use-only (RUO) assays, and specialty laboratory services.
• Directs assay development, validation, verification, implementation, and ongoing performance monitoring activities.
• Collaborates with faculty investigators and research programs to translate novel laboratory technologies into regulated testing services.
• Serves as the principal scientific consultant regarding laboratory testing methodologies, scientific interpretation, and test utilization.
• Supports development of laboratory services supporting clinical research, translational science, personalized medicine, and emerging therapeutic programs.
• Establishes and advances laboratory capabilities supporting cell and gene therapy research and clinical trials.
• Develops and expands laboratory testing portfolios to support institutional and sponsor needs.
• Oversees delivery of laboratory services including assay development, sample processing, kit preparation, central laboratory testing, sample storage, project management, and data management services.
• Ensures laboratory services meet sponsor, client, investigator, and regulatory requirements.
• Collaborates with reference laboratories, partner laboratories, and external service providers to expand testing capabilities and improve service delivery.
• Oversees chain-of-custody procedures, specimen management processes, and laboratory data reporting activities.
• Ensures implementation and maintenance of a comprehensive Quality Management System (QMS).
• Oversees compliance with CLIA, CAP, New York State Department of Health, FDA, Good Clinical Practices (GCP), and other applicable regulatory standards.
• Directs quality assurance, quality control, proficiency testing, corrective and preventative action (CAPA), and audit activities.
• Reviews and approves laboratory documentation including policies, procedures, validation reports, training records, competency assessments, and quality records.
• Maintains continuous inspection and audit readiness.
• Serves as the laboratory’s representative during regulatory inspections, accreditation reviews, sponsor audits, and agency interactions.
• Oversees implementation and documentation of corrective actions for identified deficiencies and nonconformities.
• Directs selection, implementation, validation, optimization, and management of Laboratory Information Management Systems (LIMS) and related technologies.
• Collaborates with information technology and data management teams to ensure system functionality, security, and compliance.
• Ensures compliance with data integrity requirements, electronic records regulations, cybersecurity standards, and document control practices.
• Oversees laboratory reporting systems and client-facing data deliverables.
• Recruits, develops, mentors, and retains scientific, technical, and support personnel.
• Establishes organizational structure, staffing plans, qualifications, and competency requirements for laboratory personnel.
• Provides leadership and performance management for laboratory leadership team members and staff.
• Ensures personnel receive required training, competency assessments, certifications, and continuing education.
• Fosters a culture of quality, collaboration, innovation, accountability, and continuous improvement.
• Supports business development efforts, sponsor engagement, and laboratory growth initiatives.
• Serves as a scientific and technical representative during client interactions, proposal development, and contracting activities.
• Collaborates with researchers, sponsors, industry partners, and institutional leadership to identify new service opportunities.
• Supports grant development, translational science initiatives, and academic-industry partnerships.
• Advances the laboratory’s role as a regional and national resource for clinical and translational research services.
• Promotes a safe laboratory environment and ensures compliance with biosafety, chemical safety, occupational safety, and environmental health regulations.
• Establishes and maintains laboratory safety programs designed to protect personnel, visitors, research participants, and the public.
• Performs other duties as assigned.

Education Requirement

Doctor of Medicine (MD), Doctor of Osteopathy (DO), or doctoral degree (PhD) in Clinical Laboratory Science, Medical Laboratory Science, Clinical Chemistry, Biological Sciences, Molecular Biology, Immunology, Microbiology, Genetics, Pathology, or a related scientific discipline from an accredited institution.

Experience Requirement

10 years of progressively responsible experience in clinical laboratory operations, reference laboratory sciences, central laboratory services, clinical research laboratory operations, or related laboratory environments. 5 years of leadership experience directing high-complexity laboratory testing programs across multiple laboratory disciplines. Demonstrated experience with laboratory-developed tests (LDTs), assay development, assay validation, quality systems, accreditation programs, and regulatory compliance activities. Experience managing laboratory operations, scientific personnel, budgets, laboratory information systems, and strategic growth initiatives. Experience managing laboratory operations, scientific personnel, budgets, laboratory information systems, and strategic growth initiatives. Experience with CLIA, CAP, New York State Department of Health requirements, FDA expectations, 21 CFR Part 11, and Good Clinical Practice (GCP) preferred. An equivalent combination of education and experience may be considered. All experience must be paid and in the same related field. Part-time and PRN experience will be prorated based on hours worked per week. Volunteer work and internships for academic credit are not counted.

Certifications & Licensures

Must meet qualifications to serve as a Laboratory Director for High-Complexity Testing under CLIA (42 CFR 493.1443). One of the following is required: MD or DO with applicable licensure and Board Certification in Anatomic and/or Clinical Pathology; or MD or DO meeting CLIA experience requirements for Laboratory Director qualification; or PhD with current certification by an HHS-approved board appropriate to the specialty areas directed. New York State Department of Health Clinical Laboratory Evaluation Program Certificate of Qualification as Laboratory Director in applicable laboratory categories, or eligibility to obtain within 12 months of hire. Must maintain all required licenses, certifications, permits, and credentials throughout employment.

Working Conditions

• A. Lifting, pushing, and/or pulling objects up to 50lbs: 2. Occasional (<10% of the time)
• B. Lifting, pushing, and/or pulling objects over 50lbs: 1. Never
• C. Standing or walking with objects up to 10lbs: 3. Intermittent (10% - 50% of the time)
• D. Standing or walking with objects up to 25lbs: 2. Occasional (<10% of the time)
• E. Sitting at computer workstation for extended periods: 3. Intermittent (10% - 50% of the time)
• F. Risk of back injury from moving, lifting, or positioning equipment or materials: 2. Occasional (<10% of the time)
• G. Repetitive motion: 3. Intermittent (10% - 50% of the time)
• H. Working at heights above 4 feet: 1. Never
• I. Working in confined spaces: 1. Never
• J. Risk of injuries from use of equipment on the job: 2. Occasional (<10% of the time)
• K. Job-related travel: 2. Occasional (<10% of the time)
• L. Loud noises: 2. Occasional (<10% of the time)
• M. Temperature extremes: 1. Never
• N. Hazardous chemicals and fumes including waste: 3. Intermittent (10% - 50% of the time)
• O. Radiation: 2. Occasional (<10% of the time)
• P. Burns: 2. Occasional (<10% of the time)
• Q. Cuts/Punctures: 3. Intermittent (10% - 50% of the time)
• R. Bloodborne/airborne pathogens: 3. Intermittent (10% - 50% of the time)
• S. Recombinant DNA or viral vectors: 2. Occasional (<10% of the time)
• T. Combative/violent people: 1. Never
• U. Animal handling (including carcasses): 1. Never
• V. Please specify other(s) and amount of exposure (i.e., Occasional, Intermittent or Regular): Biological specimens, clinical samples, laboratory reagents, research materials, and laboratory instrumentation; Intermittent (10% - 50% of the time).

Physical Demands

This position requires intermittent sitting at a computer workstation for extended periods of time; intermittent standing and walking throughout laboratory, research, and office environments; and performing tasks involving repetitive motions such as computer use, data review, documentation, and laboratory oversight activities. Responsibilities may include occasional lifting, carrying, pushing, and/or pulling laboratory supplies, equipment, and materials weighing up to 50 pounds. The position involves intermittent exposure to clinical specimens, biological materials, laboratory chemicals, bloodborne and airborne pathogens, cuts or punctures, and other hazards commonly associated with high-complexity clinical and research laboratories. Occasional travel may be required to attend professional meetings, sponsor visits, regulatory activities, training programs, and institutional events. This position requires regular on-site laboratory presence and oversight to support laboratory operations, personnel, quality systems, and regulatory compliance.

Our University Community

We value the well-being of each of our employees and are dedicated to creating a healthy place for everyone to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors, the University of Kentucky is a Tobacco & Drug Free campus. The University follows both the federal and state Constitutions as well as all applicable federal and state laws on nondiscrimination. The University provides equal opportunities for qualified persons in all aspects of institutional operations and does not discriminate on the basis of race, color, national origin, ethnic origin, religion, creed, age, physical or mental disability, veteran status, uniformed service, political belief, sex, sexual orientation, gender identity, gender expression, pregnancy, marital status, genetic information or social or economic status. Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen. Purpose-driven work is behind every aspect of our mission to advance Kentucky – from its economy to its health and from its culture to its levels of educational attainment. We're looking for talented, dedicated individuals to help us support this vital mission and make a difference in the lives of Kentuckians and beyond.

Join us as we build a future grounded in service, collaboration and excellence, one where your talents help move our Commonwealth forward. Beyond Blue Corporation, an affiliated entity of the University of Kentucky, is a strategic vehicle to support the university's growth. Beyond Blue is a nonprofit company that allows the university to abide by all public entity rules and laws while allowing leaders to have some separation and distinctiveness to focus on one core business. The UK Board of Trustees appoints the Beyond Blue Board of Directors and the directors of any of its subsidiary companies.