Associate Vice President for Research Compliance and Regulatory Affairs , GA

THE SEARCH

Emory University, an internationally recognized research university and one of the nation’s most comprehensive academic healthcare systems, welcomes applications and nominations for the position of Associate Vice President for Research Compliance and Regulatory Affairs (AVP). Known for exceptional teaching, research, scholarship, and service to humanity, Emory University combines nine undergraduate, graduate, and professional schools and colleges with the most inclusive—and constantly growing—health care system in the region and a sponsored research base that make it one of the great universities in the country.

Reporting directly to the Vice President for Research Administration, Dr. Robert Nobles, with a coordinated reporting relationship to the Chief Compliance Officer for the University, the AVP will provide the Emory University community with competent and comprehensive research compliance and regulatory services to facilitate its research mission. The AVP will lead ongoing needs assessments of Emory's research compliance infrastructure, in coordination and collaboration with the Vice President for Research Administration, Chief Compliance Officer, and Senior Vice President for Research to strategically identify and address any gaps or issues in a proactive manner.

As one of the nation's leading research institutions, Emory is built on an advantageous combination of resources and global partnerships. Emory supports researchers in the advancement of public scholarship, accelerating the application of discoveries, and communicating their significance to general audiences. In fiscal year 2020, Emory received $831 million in total research funding awards. The successful candidate will have significant experience in the administration of a rigorous compliance program in an academic research setting with a healthcare component. The next AVP will bring a track record of effective leadership based on a philosophy of collaboration and inclusion, and a customer-service orientation. A thorough understanding of the regulations governing sponsored research programs is required, while an advanced degree and 10 years of research compliance-related experience is preferred.

Emory University has retained Isaacson, Miller to assist in this important recruitment. Please direct all inquiries and applications as indicated at the end of this document.

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EMORY UNIVERSITY

With roots tracing back to 1836, Emory today is one of the most highly regarded research universities in the world. Emory includes nine colleges and schools: College of Arts and Sciences, , Laney Graduate School, School of Law, School of Medicine, Nell Hodgson Woodruff School of Nursing, Oxford College, Rollins School of Public Health, and Candler School of Theology. Emory is also home to multiple research centers, the largest being the Robert W. Woodruff Health Sciences Center (WHSC), which brings together the School of Medicine, Nell Hodgson Woodruff School of Nursing, Rollins School of Public Health, the Yerkes National Primate Research Center, the , Emory Global Health Institute, and Emory Healthcare to facilitate biomedical science. Emory also has a rich history of research and scholarship in the humanities, law, and business. For example, the university supports the , the Emory Center for Ethics, Halle Institute for Global Research, Emory Institute for Developing Nations, James Weldon Johnson Institute, and the Center for the Study of Law and Religion, to name but a few.

In addition to its vast academic mission, Emory Healthcare is the largest healthcare system in the state, consisting of 11 hospitals. In fiscal year 2020, EHC had $4.19 billion in net patient service revenue and provided $130.3 million in charity care. Emory Healthcare has more than 24,000 employees and 2,691 hospital beds. Annual hospital admissions total 106,623, and outpatient service visits total 5.4 million. In fiscal year 2019, EHC clinicians saw 819,168 individual patients. Emory’s operating budget for 2019 - 2020 was $6.6 billion: $2.2 billion on the university side and $4.4 billion estimated for Emory Healthcare (EHC). The campus community is made up of 8,079 undergraduate and 7,372 graduate and professional students, and over 14,000 university faculty and staff.

Emory's main campus is centrally located in the metro-Atlanta neighborhood of Druid Hills, and bordering Decatur. An international hub for healthcare, business, arts, and culture, Atlanta is the home to many world-renowned institutions and boasts an affordable cost of living. Emory also consists of the Clairmont campus, home to juniors, seniors, and graduate students, which features their Student Activity and Academic Center, in addition to the Oxford campus, which is the university's original campus and location of Oxford College, one of Emory's two liberal arts colleges. Among national universities, Emory ranked 21st in the most recent U.S. News and World Report rankings. Further information about Emory may be found at: www.emory.edu

OFFICE OF RESEARCH ADMINISTRATION

Emory's research community is thriving. In FY2020, the University received $578 million in federal sponsored research funds and an additional $253 million from state, private, and foreign sponsors. Research at Emory is conducted across the University’s educational divisions and Emory Health Care (EHC).

The Office of Research Administration (ORA), led by the Vice President for Research Administration and supported by a staff of 300, consists of 15 departments:

• Business Operations, including Human Resources; • Conflict of Interest; • Dragon Team (Quality Improvement/Quality Assurance); • Environmental Health and Safety; Emory University AVP, Research Compliance and Regulatory Affairs Page 3 of 6

• Export Control; • Institutional Animal Care and Use Committee; • Institutional Review Board; • Occupational Health and Safety • Office of Clinical Research; • Office of Research Compliance and Regulatory Affairs (new); • Office of Sponsored Programs; • Office of Technology Transfer; • Office of Trainings and Operations; • Research Administration Services; and • Research Grants and Contracts.

The primary mission of the ORA is to provide supportive and efficient administrative systems, processes, and procedures along with technical expertise that readily facilitates scholarship, research, and discovery within the Emory community from inception through dissemination and application. To that end, the ORA staff collaborates with Emory's research community through transparent communication and effective research administration services; extends and improves strategic partnerships with businesses and organizations aligned with Emory research priorities; and invests in the training and development of all staff and leadership within the division.

OFFICE OF RESEARCH COMPLIANCE AND REGULATORY AFFAIRS (ORCRA)

The Office of Research Compliance and Regulatory Affairs sits within the ORA and will be led by the AVP, who oversees the provision of regulatory and compliance training and enterprise wide communications, and the coordination, monitoring, and reporting for all research-related compliance activity across Emory University. The ORCRA consists of three broad compliance units as follows:

• Research Conflict of Interest and Conflict of Commitment - led by a Director who oversees an Assistant Director and an Analyst. • Research Security and Export Controls - led by the Export Control Compliance Officer and supported by a Deputy and an Analyst. • Research Integrity and International Contracts – led by the Deputy Research Integrity Officer, who oversees the IRB and FDA Compliance Manager, and the IACUC and Safety Compliance Specialist.

THE ROLE

Reporting to the Vice President for Research Administration, the AVP will serve as the leader of the ORCRA and as a key member of the ORA’s senior leadership team. The AVP will manage all research compliance units and will be accountable for the development and implementation of a proactive, comprehensive, and integrated compliance strategy that supports the success of Emory's entire academic research enterprise. Supported by the leads of the three ORCRA units and working in close collaboration with colleagues across the University, the AVP will work seamlessly with investigators, administrators, and regulatory agencies to ensure the efficient and effective implementation and enforcement of research compliance policies and regulatory trainings.

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To do so, the AVP will create, implement, and administer policies and procedures related to research compliance and other associated transactions related to the university's research mission, including research misconduct. Serving as the Research Integrity Officer (RIO), the AVP will coordinate with the academic units during the assessment, inquiry, and investigative phases of the process under the Policy on Research Misconduct.

Leading a team of professionals responsible for administering research related Conflicts of Interest (COI), Conflict of Commitment (COC), Export Controls, Research Security, Research Integrity, Research Misconduct Assessment and Investigations, and General Research Compliance, the AVP will also provide compliance oversight of the activities of the Human Research Protection Program, Institutional Animal Care and Use Committee (IACUC) Office, and Environmental Health and Safety Office (inclusive of the work of the Institutional Biosafety Committee (IBC), high hazard chemical safety committee, and Radiological Safety Committee (RSC)).

In so doing, the AVP will effectively support clinical trial agreements and contract negotiations related to HIPAA, data use, indemnification, risk assessment of new drugs/devices, and participant reimbursement; support and provide guidance related to IRB, IACUC, biosafety, radiological safety, and chemical safety accreditation standards; participate in regulatory site visits and inspections (e.g. USDA, OSHA complaints, etc.); and negotiate conflicts between state and federal laws with the appropriate unit leaders and ORA leadership.

To achieve these goals, the AVP will address, but not be limited to, a set of key opportunities and challenges, detailed below:

OPPORTUNITIES AND CHALLENGES

Continue to develop and manage the research compliance program

The AVP will occupy a newly created position that consolidates responsibility for research compliance under a single member of the ORA senior leadership team. The research community at Emory has long enjoyed the benefits of qualified, diligent staff in various research compliance units. Through restructuring the ORA, research compliance staff will report to the AVP who will provide these valued and talented employees with subject matter expertise, personalized mentoring, and a unified team structure and culture. The AVP will also supervise and support other changes to these units brought about by restructuring of the ORA, including clarifying roles and responsibilities, onboarding additional staff, and adopting new technologies.

To ensure the research compliance program is proactive, well known, and effective, the AVP will coordinate and supervise training, education, and assessment procedures related to compliance and responsible conduct of research (RCR) for investigators and staff members. Collaborating with administrators and research compliance staff in the schools/colleges, departments, and units, the AVP will also foster two-way communication channels during the monitoring of compliance. The successful AVP will develop, implement, and monitor a communication and training strategy regarding research compliance issues, coordinating with the AVP for Research and Research Communications team.

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Proactively foster best practices

In addition to managing existing compliance functions at Emory, the AVP will be responsible for appropriately managing risk to facilitate growth of the University’s research enterprise over the long term. To that end, the AVP will proactively develop new policies and programs as needed to ensure that research compliance at Emory keeps pace with a dynamic regulatory environment. As research compliance continues to adapt, the AVP will ensure systems are in place to educate investigators about regulatory changes and mitigate unnecessary exposure to risk.

The AVP, in conjunction with the ORA and campus partners, will identify research compliance risks within units, alert unit leaders to those risks, and guide strategies to minimize them. Navigating sensitivities and building relationships across campus, the AVP will coordinate institution-wide initiatives to prevent, detect, and respond appropriately to research compliance risks, while also recommending tools and approaches necessary to proactively encourage research compliance.

Promote research compliance throughout the University

While housed within the ORA, research compliance at Emory relies upon a variety of other University divisions to administer, enforce, and adhere to its programs and policies. The AVP will liaise with leaders throughout Emory to define and standardize systems for cooperation and specialization in various compliance functions. The AVP will develop strong relationships and effective and collaborative communications with stakeholders across campus including: external counsel, Contract Research Organizations, the University Chief Compliance Officer, Emory Healthcare Chief Compliance Officer, deans, institutional officials, regulatory/administrative committees, investigators, research staff, and representatives of professional organizations regarding research compliance and regulatory issues and solutions. Specifically, regarding Freedom of Information Act and/or other regulatory information requests, the AVP will liaise with all ORA units, University Communications, and the Office of General Counsel.

Facilitate communication and collaboration

As the ORA continues to evolve, the AVP will help to define an institutional culture that sets the appropriate balance between efficiency, compliance, and customer service while honoring the unique structures and needs of the various programs and academic units. To do so, the AVP will serve as a positive ambassador for research compliance to investigators and administrators alike and lead working groups and committees to address escalated and significant research compliance areas. Furthermore, the AVP will act as a mentor and a coach to direct reports, fostering individual professional development and encouraging synergistic collaboration between units. Above all, this individual will model the integrity, discretion, and judgment required to build and maintain trust between compliance team members and stakeholders throughout the Emory research enterprise.

Demonstrate agile leadership and manage the impact of COVID-19

It will be critical that the next AVP demonstrate astute judgement and leadership agility in the face of crises. Although the pandemic is far from predictable, the next AVP will need to see opportunities in challenging times and show a sense of optimism toward finding a shared purpose in difficult situations. Emory seeks a flexible and even keeled consensus builder with the ability to find comfort in ambiguity, Emory University AVP, Research Compliance and Regulatory Affairs Page 6 of 6

while leading the research compliance enterprise to ensure all campus community constituents are compliant with university research policy.

QUALIFICATIONS AND CHARACTERISTICS

The successful candidate will have significant experience in the administration and oversight of a rigorous compliance program in an academic research setting. This individual will have a track record of effective leadership based on a philosophy of collaboration and a customer-service orientation. A thorough understanding of the regulations governing sponsored research programs is required.

Other desired skills, experience, and personal qualities include:

• Strong leadership and management experience, with a proven ability to anticipate and address organizational needs; • Experience with intra-organizational training; • Experience implementing and overseeing compliance systems; • Demonstrated ability to work at all levels of an organization on potentially complex and sensitive issues; • A track record of productive, collaborative relationships with research faculty; • Demonstrated success working with a diverse community of researchers, executives, and staff; • Excellent communication, presentation, and interpersonal skills; • Extensive experience in compliance, including a working knowledge of federal and state laws and regulations impacting higher education; • Higher education and/or academic medical center experience preferred; • A strong moral compass and unquestionable discretion; • Experience working in or closely associated with an academic Office of General Counsel preferred; • A terminal degree (e.g. JD, MBA, PhD, etc.) and 10 years of regulatory compliance or related experience is strongly preferred; • Compliance Certifications are highly encouraged (or should be pursued within two years of employment), including (but not limited to) Certified Compliance and Ethics Professional (CCEP), and/or Certified Risk and Compliance Management Professional (CRCMP); • Prior experience as a research investigator and/or certification as a research professional is preferred.

TO APPLY: Inquiries, nominations, and applications should be sent in strict confidence to:

Rebecca Kennedy, Partner Andy Marshall, Senior Associate Isaacson, Miller www.imseach.com/7893

EQUAL EMPLOYMENT OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER: Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran’s status, or any factor that is a prohibited consideration under applicable law.