Research Director, Duke Margolis Institute for Health Policy Hybrid (Washington DC or Durham NC)

Duke University:

 

Duke University was created in 1924 through an indenture of trust by James Buchanan Duke. Today, Duke is regarded as one of America’s leading research universities. Located in Durham, North Carolina, Duke is positioned in the heart of the Research Triangle, which is ranked annually as one of the best places in the country to work and live. Duke has more than 15,000 students who study and conduct research in its 10 undergraduate, graduate and professional schools. With about 40,000 employees, Duke is the third largest private employer in North Carolina, and it now has international programs in more than 150 countries.

 

 

 

Research Director, Medical Product Development and Regulatory Policy

Robert J. Margolis, MD, Institute for Health Policy

 

The Robert J. Margolis, MD, Institute for Health Policy at Duke University (Duke-Margolis) seeks to address critical health policy challenges and improve health, health equity, and the value of health care through practical, innovative, and evidence-based policy solutions. The interdisciplinary nature of Duke-Margolis brings together policy experts, researchers, health care professionals, and students from across Duke’s schools of medicine, nursing, law, public policy, business, and engineering, and fosters extensive relationships with stakeholders both internal and external. These relationships span foundations, private sector organizations, state and federal governments, and global entities. The Institute fosters excellence, leadership, and scholarship at every level.

 

Occupational Summary

 

Duke-Margolis has an opening for a Research Director to join its Biomedical Innovation team.

 

This position leads the strategic design, management, and direction of the health policy program area within Duke-Margolis focused on the development and regulation of medical products. The Research Director is responsible for oversight and direction of a portfolio of projects within this area that are managed either personally or by staff supervised by the individual in this role. The Research Director is a subject matter expert across a range of dynamic FDA regulatory policy areas including early-stage clinical development, clinical trial modernization, medical product review processes, innovative manufacturing, and data analysis and surveillance. The role entails regular interaction with an array of external project sponsors and collaborators including government agencies, academic centers, advocacy organizations, medical product developers and manufacturers, health care organizations, and technology and AI companies. The individual collaborates with Duke-Margolis executive leadership and manages implementation of research and policy objectives to contribute to successful execution of the Institute’s strategic goals. The Research Director has significant responsibility for cultivation of funding opportunities and management of program area personnel.

 

Duke-Margolis has offices in both Washington, DC and on Duke's main campus in Durham, NC. Washington, DC is the preferred location for this position as substantial components of the work will be in-person in the DC area, though exceptional NC candidates willing to travel may be considered. Employees are currently working in a hybrid capacity with a combination of teleworking locally to the base office area (DC/MD/VA or NC, respectively) and in-person team collaboration days.

 

Work Performed

 

Program and Research Leadership

 

Collaborate with the Duke-Margolis leadership team, Institute faculty, and senior researchers to develop project direction, focus, priorities, and strategies to meet the research and project needs within a program area in the Biomedical Innovation workstream. Manage execution.

 

Recognized as a context expert in specific area(s) of expertise, specifically in areas of medical product development and regulatory policy. Areas of particular focus include early-stage clinical development, clinical trial modernization, medical product review processes, innovative manufacturing, and data analysis and surveillance with an emphasis on FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Provide content leadership and direct project staff in substantive content components of work products.

 

Interact closely with external collaborators including government agencies, research and/or policy organizations, industry, trade associations, patient groups, health sy