Director, Regenerative Medicine Commercialization - ARPA-H NITRO GRANT

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

 

Director, Regenerative Medicine Commercialization

 

 

Occupational Summary

This 100% grant-funded position is responsible for managing a federally funded, multi-center regenerative medicine program. This position will oversee diverse workstreams, including research, technical, commercialization, and equity initiatives while supporting the transition of research from bench to bedside. The role includes working with others on the team and an advisory board in the development of an appropriate commercialization strategies, potentially forming a new corporation (newco) or equivalent. Coordination with the Office for Translation & Commercialization will be required. The position will also manage regulatory approval processes with consultants and guide the overall product commercialization pathway. This role will also serve as the primary liaison between the project team, stakeholders, and the funding agency and support the program's administrative, financial, and operational activities. This role offers the opportunity to work at the intersection of research and industry, driving meaningful impact through the commercialization of cutting-edge university technology.
 

Work Performed:
 

Workstream Coordination: (15%)

Coordinate efforts across diverse workstreams, including research, technical, commercialization, and equity-related activities.

Facilitate communication and information sharing between project sites, key stakeholders, and the funding agency, ensuring alignment and transparency.

Work closely with the Principal Investigator (PI), scientific manager, and equity officer to ensure that project goals are met and timelines are adhered to across all workstreams.
 

Project Monitoring & Deadline Management: (15%)

Track critical milestones, deliverables, and timelines to monitor project progress.

Identify risks and develop and implement mitigation strategies to ensure projects remain on track and   within scope.

Maintain an updated project dashboard to facilitate real-time status updates for stakeholders and the funding agency.
 

Budget Management: (15%)

Collaborate with the PI and financial support team to develop, monitor, and manage project budgets, ensuring accurate forecasting and financial oversight.

Ensure full compliance with grant funding requirements and provide comprehensive financial statements and reports to the funding agency as needed.
 

Commercialization & New Corporation Development: (25%)

Lead commercialization efforts, including market analysis, regulatory approval strategies, and product launch plans for research outputs transitioning to practical application.

Collaborate with the others on the team, the Office for Translation & Commercialization, and with advice form an advisory board to determine the most appropriate commercialization strategy, including market analyses, IP protection, pitch deck development and assistance with creating a new corporation (newco) to bring the technology to market.

Oversee the regulatory pathway, guiding the research team through pre-clinical, clinical, and regulatory approval phases for the developed technologies.

Facilitate the transition from research to commercial application, ensuring