Sr Director, Human, Animal, and Laboratory Investigations

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Job Title:
Sr Director, Human, Animal, and Laboratory Investigations

Department:
ERIK | Administration

The Enterprise for Research, Innovation and Knowledge (ERIK) Senior Director for Human, Animal and Laboratory Investigations leads and manages a qualified team responsible for overseeing research control, audit and investigations of human and animal subjects and biosafety. Develops and oversees the working relationships and segregation of duties between ERIK and supporting colleges. Leads, plans, directs, implements, coordinates, and enhances the effectiveness and efficiency of all related university research compliance programs, to include audits and investigations.  

Works closely with the Associate Vice President (AVP) for Research Integrity and Investigations and ERIK operational leaders (e.g. ORRP, ACUP) to develop long-term compliance strategies and key reporting metrics as it relates to human and animal subjects, and biosafety protocols and research investigations. With operational leaders, ensures the university’s compliance with federal, state, local laws, private sponsor requirements, and university policies to support and promote ethical research practices throughout the university. Works closely with the AVP and other ERIK leaders to develop and communicate compliance training, monitoring, auditing, and reporting.  

Ensures compliance with NIH, OHRP, and FDA regulations and AAHRPP requirements for human subjects research, and NIH OLAW guidelines, USDA regulations, and other AAALAC reference resources. Partners with EHS on matters related to laboratory safety and controls.  Partners with university organizations to develop and ensure long-term planning initiatives are met, including the design and renovation of units to meet regulatory requirements.  

Specific Roles: While operational leaders within ORRP will manage oversight of all institutional review boards, post-approval monitoring, quality improvement, and related operations, this position will oversee in-depth audits and investigations related to human subject research and ensure alignment of all related activities of ORRP and the colleges, to include oversight of all monitoring and audit approach.  Allegations for audits or investigations may be referred from the IRBs, OUCI, or other university stakeholders/agencies concerned with the rights and welfare of human research participants.    

While operational leaders within ACUP will manage oversight of IACUC operations including post-approval monitoring through regular inspections, quality improvement activities, and related operations, this position will oversee in-depth audits and investigations related to animal research and ensure alignment of all related activities of ACUP and the colleges, to include oversight of all monitoring and audit activities.  Observations for in-depth audit or allegations for investigation may be referred from the IACUC, ULAR staff, OUCI, or other university stakeholders/agencies concerned with the appropriate care and use of animals in research.  

Works with ORRP, IACUC, and EHS to address compliance through controls and investigations related to biosafety and laboratory safety.  This includes research involving hazardous chemicals, biohazards, gene and cell therapies, and other materials overseen by the IBC and EHS.  Oversees audits of nontherapeutic use of controlled substances in research.  

Minimum Education & Qualifications Required

Bachelor’s degree in regulatory science or related fields. Minimum of 12 years of relevant work experience.  

Ten (10) years of experience in research operations and/or compliance, including considerable knowledge of federal regulations such as FDA, OHRP, OLAW, USDA, Ohio Ethics, DHHS, HIPAA, and NIH guidelines.  

Working knowledge of human, animal, and biosafety research. 

Extensive experience in research compliance operations, as well as knowledge of federal, state, local and/or private sponsor regulations, requirements, and laws.  

Considerable experience working in teams with qualified leaders and experts, to include experience in research regulatory and compliance matters. 

Considerable knowledge of policies and regulations, state law and university policies and guidelines pertaining to human and animal subjects research, and research-related workplace safety (e.g. biosafety, cell and gene therapy).  

Ability to develop strong relationships and exercise authority through influencing others. 

Additional Education & Qualifications Desired

Advanced or doctoral degree (PhD or MD) preferred in regulatory science or laboratory-based research discipline.

Ten (10) or more years of demonstrated ability to exercise authority through influencing others and building strong relationships.  

Ten (10) or more years of demonstrated ability to manage competing priorities, operate with ambiguities, and communicate to a complex set of audiences.  

Considerable experience leading highly complex compliance operations and providing strategic leadership to the organization, to include the conducting of audits or investigations.  

Experience working with sponsored research and compliance issues in higher education. 

Additional Information:

The pay range for this job profile is $135,000 - $180,500. The offer for this position will fall within this range based on multiple factors including internal equity, unit’s available budget, and the candidate’s qualifications.

Position Mapping:

Function: Research Administration

Sub function: Research Compliance

Band: Managerial

Career Level: 5

This position is based in Columbus, Ohio. We strive to offer a competitive salary that is commensurate with education and relevant experience. The Ohio State University offers competitive and comprehensive benefit options. Explore https://hr.osu.edu/careers/  for more information.  

Location:
University Square South (1032)

Position Type:
Regular

Scheduled Hours:
40

Shift:
First Shift

Final candidates are subject to successful completion of a background check.  A drug screen or physical may be required during the post offer process.

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