A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The Michigan Institute for Clinical & Health Research (MICHR) is the home of the University of Michigan's Clinical and Translational Science Award from the National Institutes of Health. MICHR is part of a national, collaborative consortium that is focused on bringing more health solutions to all people more quickly by advancing translational science. The field of translational science aims to build an evidence base of scientific and operational approaches that improve the efficiency, effectiveness, and impact of translational research across a range of diseases and conditions. MICHR has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist; developing novel solutions to these challenges; demonstrating their effectiveness; and disseminating improvements widely. MICHR is a dynamic organization that serves as a hub of innovation and experimentation to advance research in the science of translation and accelerate the realization of interventions that improve human health.

MICHR is seeking a skilled Program Director to lead the IND/IDE Investigator Assistance Program (MIAP) and Study Management & Monitoring (SMM) teams. This dynamic leader will play a pivotal role in advancing MICHR's mission by driving innovation in regulatory support and program operations for clinical and translational research. As a recognized expert, the Program Director will guide high-impact initiatives, shape strategic direction, and ensure operational excellence across MICHR's regulatory portfolios. In this role, you will spearhead the day-to-day management of the MIAP and SMM teams, champion collaborative problem-solving, and cultivate efficiencies. You will leverage deep regulatory expertise to mentor and develop staff, oversee sponsor-investigator interactions with the FDA, and ensure rigorous compliance with evolving federal guidelines. 

Michigan Medicine improves the health of patients, populations, and communities through excellence in education, patient care, community service, research, and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

60% Program Leadership Activities

1. Responsible for providing leadership and professional expertise or services to customers and MIAP and SMM staff through knowledge and skills or leveraging the skills of others; 
2. Manages daily operation of the MIAP and SMM teams. Establishes operational objectives and assignments, and appropriately delegates assignments to subordinates. 
3. Uses independent judgment when making decisions, assesses work load, work complexity, outcome results and collaborates with other programs or departments when making recommendations that may significantly impact others.  Searches out appropriate course of action within the context of policies and procedures that support appropriate decision making.
4. Helps set and is guided primarily by established policies, precedents and professional knowledge and/or by projects/program objectives established by deans, directors, chairs, or other (divisional) leadership. 
5. Recommends program strategic direction and provides leadership in the operational changes for MIAP and SMM.  Demonstrates an understanding of how the program(s) fit into the established goals of the University.
6. Contributes to the overall strategy, direction and vision for all functional areas of responsibility.
7. Has measurable impact on operational effectiveness, attainment of department/unit objectives, service to customers and attainment of research goals.
8. Create and Maintains IND/IDE/Monitoring SOPs, standard practice documents, tools, and templates 
9. Active Membership in national regulatory support professional organizations. 

10% Project Lead Activities

1. Manage and oversee UM Sponsor-Investigator FDA approvals for clinical research projects involving drugs, devices, or biologics including INDs and IDEs
2. Author, prepare and contribute to IND and IDE filings, pre-submission requests, meeting packages, responses to FDA inquiries, and life-cycle maintenance submissions to FDA
3. Communicate with the FDA regarding regulatory submissions, meeting requests, and other topics
4. Provide regulatory guidance, strategy and expertise to UM sponsor-investigators and study teams
5. Critically review clinical protocols, eResearch applications, informed consents, and other documents to ensure compliance with regulatory requirements

10% HR Activities

1. Human resource management duties include interviewing, selecting and training of employees; setting and adjusting their rates of pay and hours of work; planning and directing their work; appraising their productivity and efficiency for the purpose of recommending promotions or other changes in their status; handling their complaints and grievances and disciplining them when necessary. 
2. Management responsibilities include the authority to hire, fire, salary changes, performance coaching, training and development or promote assigned employees or make recommendations that are given particular weight.  Ensures consistent application of organizational and departmental policies, etc. 
3. Completes performance evaluations and conducts performance reviews.

5% Budget Activities

1. Assumes financial responsibility for MIAP/SMM in budget preparation, execution, justifications, and reconciliation.  Demonstrates the ability to manage assigned budget responsibilities.
2. Ensures team appropriately documents time and effort in applicable tracking tools. Demonstrates the ability to use collected data in team management through the assessment of productive and non-productive time.   

5% Education Activities

1. Monitor and interpret changes in FDA regulations and guidance documents; effectively communicate relevant updates to internal and external stakeholders to ensure ongoing compliance.
2. Provide regulatory guidance and consultation and serve as subject matter expert on FDA regulations for internal units, such as Institutional Review Board (IRB), Human Research Protection Program (HRPP) related units, Clinical Trials Support Units, Regulatory Affairs, Office of General Counsel, and others as needed.
3. Creating and providing regulatory education, seminars, and training to investigators, Coordinators, monitors, IRB, and other research/regulatory personnel both internal and external to the Institution.

5% Special Projects

1. Engages in special project assignments that meet the Office of Research mission, vision, goals and program needs.  Provides team members with opportunities to participate and gain professional experience through assigned tasks and projects. 

5% Monitoring Oversight

1. Critically review Monitoring plans and monitoring visit reports to ensure appropriate, risk based, and to ensure findings are clear and actionable
2. Elevate any monitoring issues to other Internal Stakeholders as needed, such as the Office of Regulatory Affairs, The Office or Research Compliance Review, IRBMED

• Bachelor's degree and considerable professional experience with reasonable prior management, supervisory or team leader experience is required. 
• At least 10 years of experience working in Regulatory Affairs, preferrable at an academic institution.
• Experience submitting and maintaining INDs and IDEs. 
• Obtain and maintain Regulatory Affairs Certifications (RAC). 
• Under FLSA, incumbents in this position meet the criteria for exempt status.

• Experience with Clinical Trial monitoring, or Certified Clinical Research Associate (CCRA), Academy of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) certification 
• Experience preparing and submitting Pre-IND and Q-Submission meeting requests

Day Shift 

North Campus Research Complex, Ann Arbor, MI 

Note: this position is hybrid, with occasional travel to Ann Arbor, MI required. 

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third-party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.