The University of Michigan Medical School seeks a nationally recognized, well informed, and visionary leader to support and advance our clinical, research and education missions through the services offered by the Office of Regulatory Affairs. The Associate Dean for Regulatory Affairs is responsible for the successful leadership and strategic management of the office, in accordance with the mission and vision of the Medical School and Michigan Medicine and its bylaws. The Associate Dean for Regulatory Affairs serves as a representative of the Dean and the Medical School to internal and external constituencies. This leader will build on the institution’s significant strengths in supporting a strong regulatory foundation for the Medical School’s patient care, research and service missions.
The Associate Dean for Regulatory Affairs will lead the Office of Regulatory Affairs to sustain and enhance the strong foundation of regulatory good-standing upon which the Medical School’s missions flourish. The Office and the Associate Dean will strive to assist faculty and staff in understanding relevant regulations, institutional policies, and other professionally accepted standards that impact the activities and reputation of the Medical School. Further, the Associate Dean will work with faculty to address concerns in the regulatory realm, to mitigate noncompliance risks and resolve noncompliance when it occurs, and to bring faculty/staff authorship and research grant disputes to resolution.
The Office of Regulatory Affairs oversees conflicts of interest (COI) for faculty and staff in research, clinical and educational areas. The Office manages two COI committees which meet monthly: the MEDCOI Board for Research and the Clinical and Educational COI Committee dealing with policies and potential conflicts in the educational and clinical missions. Further, the Associate Dean and COI Manager serve on the University Institutional COI Committee. Office staff oversee the annual outside interest M-Inform disclosure process for faculty and professional staff, assuring a very high level of compliance with the disclosure process. The Associate Dean reviews the disclosures for departmental chairs and assists the chairs with questions regarding their review of faculty and staff disclosures. As alluded to above, both the MEDCOI Board and the COI Committee serve the Medical School in developing policies which govern the interactions of Medical School personnel (faculty, staff, trainees, students) with biomedical industries.
The Office of Regulatory Affairs offers expertise, support, and assistance to University of Michigan faculty and staff with registration and reporting of clinical research trials in ClinicalTrials.gov. The office also serves as the lead administrator of the ClinicalTrials.gov Protocol Registration System, which facilitates the provision of account administration, technical advice, consulting, problem solving, and compliance monitoring services.
Assuring laboratory safety for faculty and staff is an additional key function of the Office. The Office participates in the University initiative regarding laboratory safety and supports the Medical School Laboratory Safety Executive Committee which meets monthly.
Further, the Office of Regulatory Affairs assists faculty with interactions with governmental oversight agencies, such as the FDA, including preparation for, hosting of, and follow-up to inspections. The office also drafts comments for submission regarding selected proposed federal regulations, policies, and guidance. Effort is estimated at .50-.60 FTE with significant on-site presence required.
OVERALL STRATEGIC RESPONSIBILITIES
Operationalize a Vision for the Office of Regulatory Affairs.
Effectively articulate the mission, vision and values and lead in their execution and delivery.
Be a role model for integrity, scholarship, professional competence, and collegiality and collaboration across the organization.
Support interdisciplinary collaboration to catalyze Michigan Medicine’s tripartite mission of patient care, research and education. Strengthen opportunities to engage the next generation of health care providers and health scholars.
Be an effective institutional leader, helping in the development of network strategies and outreach opportunities.
Promote a culture of diversity, equity and inclusion.
Provide a forward thinking data-driven environment.
DESIRED PERSONAL CHARACTERISTICS, QUALIFICATIONS AND ATTRIBUTES
The Associate Dean for Regulatory Affairs should possess:
Communication skills –Exemplary interpersonal skills that demonstrate diplomacy and accessibility. The Associate Dean should be an approachable, collegial, an attentive listener, and able to build a team that moves towards common goals in a transparent manner.
Integrity – Personal standard of behavior, including discretion in sensitive or confidential matters, that will be a model for the organization and will inspire collaboration. One who is a role model and well respected.
Judgement – Thoughtful, circumspect, objective, and reserved until fact-finding has completed. Able to incorporate an appropriate balance of risk relative to regulatory burden in policy and decision making.
Vision – Forward thinking, responsive to needs of the physicians, scientists, learners, staff, patients and the health system. Able to convey a clear, shared vision with an alignment of efforts.
Intellectualand analytical skills – Ability to drive cogent planning and establish robust management systems.
Political acumen and collaborative skills –Skills to build consensus and collaboration among strong, diverse and sometimes competing individuals and programs.
Commitment to accessibility – Invested in the work environment for all members of departments, sensitive to their areas of dissatisfaction, and celebratory of their areas of growth and achievement.
Diversitymindset – Demonstrated commitment to diversity, equity and inclusion and an appreciation for its important contributions to excellence. One who is objective and diplomatic.
Organizational knowledge – Demonstrated knowledge of the medical school, health system, the clinical and basic sciences and campus collaborations/initiatives.
The Associate Dean for Regulatory Affairs should be a:
Motivator/mentor –Motivates individuals to be team players, collegial, supportive, and willing to share information. Committed to developing faculty, trainees and staff for all departmental and institutional leadership roles.
Change agent –Possess creativity to reengineer and innovate existing practices.
Decisive leader – Combines a sense of equanimity with humor to sustain intense, productive and collaborative leadership effort.
Experienced in human resources –Possesses ability to be objective while handling sensitive matters; be an advocate for faculty while maintaining the upmost ethical standards of the University of Michigan.
Team player – Collaborates on multiple levels with research, clinical and administrative staff.
Results-oriented achiever – Utilizes appropriate problem solving tools and techniques that align with the culture in the process of obtaining results.
Educator – Assists in educating the Michigan Medicine community on regulatory policies and guidance.
Provide leadership, expertise, and advice on regulatory issues that impact the activities of the Medical School and Health System, including human subject and animal research.
Build and maintain regulatory and institutional knowledge and relationships with stakeholders.
Assess risks relative to burdens and anticipate regulatory and institutional needs/gaps.
Facilitate appropriate resolutions to regulatory and faculty issues.
This individual will act as a liaison within the institution and beyond to oversee and participate in the following:
Develop and maintain relationships with Federal and State agencies and stakeholders to enable the Medical School to anticipate and plan for new regulations.
Act as liaison on regulatory issues to the UMMS Office of Research, Michigan Medicine Corporate Compliance Office and Compliance Committee, EVPMA, UM Office of Research (UMOR), Office of Research Compliance Review (ORCR), the UM Ethics, Integrity, and Compliance Committee (UMEICC) and other institutional regulatory oversight units.
Participate on 50+ committees at UM; to represent, as well as to spot potential opportunities and problems.
Partner with 30+ UM offices/units; to help resolve issues and guide in wayfinding.
Attend/serve 15+ professional associations, etc.; in order to listen and contribute to the national dialog.
Key Primary Responsibilities
Conflict of Interest
Clinical trial registration and reporting
Authorship/grant dispute resolution
Assist the UM Research Integrity Officer (RIO) in research misconduct reviews, as determined by the RIO
Align with priorities and approaches of the school and university.
Implement and participate in the missions of the Medical School, specifically programs and initiatives of the Executive Vice President for Medical Affairs (EVPMA)/Dean and delegates.
Understand and adhere to the Regents’ Bylaws, the University’s Standard Practice Guide, the Medical School Bylaws and policies, and the University of Michigan Medical Group Bylaws.
Participate in cultural and organizational needs and activities of the University, Health System and Medical School.
Other leadership responsibilities
Ensure fiduciary and regulatory agency compliance related to the office activities and responsibly manage conflict of interest and commitment, policy and procedural compliance. Avoid conflict of interest, conflict of commitment and the appearance of such conflicts.
Implement the missions of the school, specifically programs and initiatives of the EVPMA/Dean and delegates, which may include parallel responsibilities for managing issues related to interdepartmental or extra departmental units, such as a center or facility with parallel expectations.
The successful candidate will have an MD and has a record of outstanding scholarly, collaborative, and mentoring accomplishments, all completed with high integrity. Strong preference will be given to individuals with deep knowledge of the clinical and research (basic, translational and clinical) environments at Michigan Medicine.
Additionally, a successful candidate must be highly collaborative, motivated and have significant experience building, leading and unifying interdisciplinary teams. Additionally, the candidate should have a proven track record in developing programs; dedication to the tripartite mission; a demonstrated commitment to education, as well as diversity, equity and inclusion; and significant administrative and budgetary experience in a matrix-based organization.
The Associate Dean for Regulatory Affairs reports to the Executive Vice Dean for Academic Affairs of the Medical School.
NOMINATIONS AND APPLICATIONS
The search advisory committee is being chaired by Diane M. Harper, M.D., M.P.H., M.S., senior associate director for the Michigan Institute for Clinical and Health Research and Professor of Family Medicine. Nominations should be sent to Tim Keeler (email@example.com) by October 18.
Interviews will be held on December 9, 10, 11, 16 and 18.
Candidates interested in the position should submit a CV and a 1-2 page letter of interest by November 8 to our application website: http://apply.interfolio.com/68724 <http://apply.interfolio.com/68724>
WEBSITES FOR ADDITIONAL INFORMATION
Office of Regulatory Affairs: https://medicine.umich.edu/medschool/about/key-initiatives/ethics-integrity/office-regulatory-affairs
Michigan Medicine seeks to recruit and retain a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and to maintain the excellence of the University. We welcome applications from anyone who would bring additional dimensions to the University’s research, teaching, and clinical mission, including women, members of minority groups, protected veterans, and individuals with disabilities. The University of Michigan is committed to a policy of nondiscrimination and equal opportunity for all persons and will not discriminate against any individual because of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, height, weight, or veteran status. The University of Michigan is an Equal Employment Opportunity/Affirmative Action Employer.
Internal Number: 1012019
About University of Michigan Medical School
At Michigan Medicine, we advance health to serve Michigan and the world. We pursue excellence every day in our three hospitals, 125 clinics and home care operations that handle more than 2.3 million outpatient visits a year, as well as educate the next generation of physicians, health professionals and scientists in our U-M Medical School.
Michigan Medicine includes the top ranked U-M Medical School and the University of Michigan Health System, which includes the C.S. Mott Children’s Hospital, Von Voigtlander Women’s Hospital, University Hospital, the Frankel Cardiovascular Center and the Rogel Cancer Center. Michigan Medicine’s adult hospitals were ranked no. 11 in the nation by U.S. News and World Report in 2019-20 and C.S. Mott Children’s Hospital was the only children’s hospital in Michigan nationally ranked in all 10 pediatric specialties analyzed by U.S. News and World Report for 2019-20. The U-M Medical School is one of the nation's biomedical research powerhouses, with total research funding of more than $500 million.
More information is available at www.michiganmedicine.org.