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.
60% Program Leadership Activities
- 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;
- Manages daily operation of the MIAP and SMM teams. Establishes operational objectives and assignments, and appropriately delegates assignments to subordinates.
- 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.
- 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.
- 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.
- Contributes to the overall strategy, direction and vision for all functiona
