About
About David Fineberg, MD, MBA

DF Clinical LLC provides physician led medical monitoring and clinical development support from study concept through the final clinical study report. Founded by David Fineberg, MD, MBA, the firm combines senior, CMO level medical leadership with sustained engagement with investigators and site teams.
David's experience spans study concept and strategy, protocol development, site feasibility and startup, enrollment support, medical monitoring and safety oversight, DSMB coordination, and data interpretation through the clinical study report. His medical and business training combines clinical judgment with practical study execution.
David is now expanding this work to train and mentor both medical monitors and effective site engagement professionals, equipping them with the clinical understanding and relationship building skills needed to engage investigators and coordinators. Training emphasizes substantive, peer to peer medical dialogue, practical problem solving, and sustained site support. The aim is to strengthen investigator commitment, help sites give a study greater priority within their research portfolios, and improve enrollment.
That engagement begins before site startup. DF Clinical works with site teams to critically assess enrollment assumptions against the available patient population, protocol eligibility requirements, competing studies, referral pathways, and staffing capacity. By testing the rationale behind site estimates and developing practical recruitment plans, the firm helps establish more realistic, defensible enrollment projections. This work is described in full on the clinical trial site feasibility and enrollment support page.
Throughout study conduct, close site relationships help translate those plans into action. Medical monitors and site engagement professionals are trained to recognize emerging obstacles, facilitate resolution of clinical questions, and revisit enrollment expectations as actual screening experience develops. Medical oversight and enrollment support remain grounded in participant safety, protocol compliance, and investigator judgment.
Each engagement is led by senior medical expertise and supported, as needed, by a curated network of medical monitors, safety and regulatory professionals, and clinical operations specialists. This structure allows DF Clinical to match support to a program's needs while maintaining clear medical accountability and continuity with sites.
Based in Cary, North Carolina, in the Research Triangle, DF Clinical serves biotechnology and pharmaceutical companies, contract research organizations, and investigator teams across the globe.
Career
Surgical judgment. Executive experience. Direct site engagement.
David Fineberg, MD, MBA, completed training in general and reconstructive surgery and practiced as a plastic and reconstructive surgeon before entering industry. That foundation continues to shape his work: careful assessment of the individual patient, sound clinical judgment under pressure, and accountability for medical decisions.
His industry career began in drug safety and quality and progressed through clinical development leadership roles from Medical Director to Chief Medical Officer across biotechnology and pharmaceutical organizations.
His experience spans first-in-human studies through Phase 4 programs, with responsibilities encompassing FDA interactions, including pre-IND meetings, responses to clinical holds, and negotiation of Phase 3 study designs, as well as safety governance and oversight of CROs and clinical vendors. He brings that perspective to both program strategy and daily study execution, from protocol development and site preparation to eligibility decisions, safety assessment, and interpretation of results. A particular strength is direct, peer-to-peer engagement with investigators, building the clinical rapport and commitment needed to address enrollment barriers and help sites prioritize a study.
David is now extending that experience through training and mentorship for medical monitors and site engagement professionals. His approach develops the clinical understanding, communication skills, and follow-through needed to build productive investigator relationships. Before startup, that means critically assessing enrollment assumptions and helping sites develop realistic, defensible projections.
This combination of surgical training, executive leadership, and direct study involvement allows David to connect development decisions with the realities of patient care and site performance, and to train others to do the same.
Current Roles
Present appointments
Medical Director
Sitero, a contract research organization
Advisory Board Member
Spectral Medical Inc.
Consulting clinical development leadership
DF Clinical LLC
Selected Publications
Peer reviewed publications
The full publication and citation record is available on Google Scholar and ResearchGate.
- Vincent JL, Francois B, Zabolotskikh I, et al., including Fineberg D, for the SCARLET Trial Group. Effect of recombinant human soluble thrombomodulin on mortality in patients with sepsis-associated coagulopathy: The SCARLET randomized clinical trial. JAMA. 2019;321:1993-2002.
- Levi M, Tanaka K, Radford A, Kayanoki T, Fineberg D, Hoppensteadt D, Fareed J. Association between effect of recombinant human soluble thrombomodulin (ART-123) on baseline coagulation biomarkers and mortality in sepsis-associated coagulopathy. Critical Care Medicine. 2020;48(8):1140-1147.
- Francois B, Fiancette M, Helms J, et al., Fineberg D, Vincent JL, Wittebole X. Efficacy and safety of human soluble thrombomodulin (ART-123) for treatment of patients in France with sepsis-associated coagulopathy: A post hoc analysis of SCARLET. Annals of Intensive Care. 2021;11:53.
- Marder J, Comerota A, Shlansky-Goldberg R, Davis JP, Deng C, Hanna K, Fineberg D. Safety of catheter-delivered plasmin in patients with acute lower extremity arterial or bypass graft occlusion: Phase I results. Journal of Thrombosis and Haemostasis. 2012;10:985-991.
- Fineberg DA, Kesavadas T, Pape D. Development of an interactive teaching system based on motion synchrony between physical and virtual objects. Studies in Health Technology and Informatics. 2003;94:79-85.
Patents
Patents
- Therapeutic Delivery Devices, Systems, and Methods. U.S. Patent No. 8,840,637 (2010).
- System and Method for Enhancing Emotional Regulation Through Interoceptive Sensory Mapping. U.S. Patent Application No. 19/260,740 (2024).
Education & Training
Education and training
- Global Executive MBA, Kenan-Flagler Business School, University of North Carolina at Chapel Hill
- Doctor of Medicine, Tel Aviv University
- Resident, Plastic and Reconstructive Surgery, Albert Einstein College of Medicine
- Resident, General Surgery, State University of New York at Buffalo
- BS Biology, cum laude, Syracuse University
A short conversation is the practical next step.
Describe where the program stands and what decision is in front of you, and we will tell you plainly whether this is the right kind of help.