Clinical Development Leadership
Fractional chief medical officer and senior clinical development lead engagements: development strategy, program design, clinical judgment, regulatory strategy and interactions
ServicesClinical Development Consulting
Medical services for biopharma clinical programs, end-to-end
DF Clinical is a clinical development consulting practice that provides experienced physician leadership across the lifecycle: development strategy, trial design and execution, medical monitoring, safety oversight, and regulatory interactions
- IND Enabling through Phase 4 Global Programs
- Support trials across 25 countries
- Published in JAMA
What DF Clinical Does
Clinical Development Consulting: Areas of Engagement
Provide Medical Services from trial concept, indication selection, population selection, trial design, regulatory document development, study feasibility, interrogation of enrollment projections and site selection, and oversight throughout the conduct of the trial through the CSR.
Medical Monitoring & Safety Oversight
Ongoing medical review, eligibility and safety decisions, adverse event assessment, and safety governance structures including data safety monitoring boards.
Medical monitoringEnrollment Support
Proactive and ongoing enrollment support with projection verification and investigator stewardship
Site feasibility and enrollmentThe Difference
Strategy and Execution, hand in hand
Most senior clinical advisors operate at the strategy level. They review development plans, advise on study design, and recommend regulatory pathways. Turning that strategy into a running clinical program often falls to a team without the same depth of experience.
DF Clinical works at both levels: clinical and regulatory strategy at the top, and hands on clinical execution underneath it. That means not only designing the development plan, but managing the realities that determine whether it succeeds: preparing for FDA meetings, implementing protocols, resolving eligibility questions, assessing the impact of protocol amendments on the study population, evaluating safety signals, supporting enrollment after hours, providing CRO oversight and direction, remediating sites that are not enrolling to projections, and carrying the program through finalization of the clinical study report.
Work performed at the execution level
- Protocol development
- Eligibility decisions
- Medical monitoring
- Safety governance
- CRO oversight
- Site selection
- Investigator engagement
- Enrollment troubleshooting
- FDA interactions
- DSMBs
- Data interpretation
- Clinical study reports
Therapeutic Focus
Areas of concentrated experience
Oncology
Solid tumors including metastatic colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer. Modalities span cancer immunotherapy, allogeneic cell therapy, oncolytic viruses, and targeted small molecules.
Therapeutic area expertiseImmunology, Inflammation & Critical Care
Sepsis and coagulopathy, hematology and immunology biologics, and monoclonal antibody programs.
Therapeutic area expertiseClinical Development Across Therapeutic Areas
The general capability: development strategy, trial design, safety oversight, and regulatory interaction applied wherever the clinical question sits.
Therapeutic area expertiseWho We Work With
Organizations that need senior clinical depth
Emerging Biotech
Senior clinical leadership at the level a program requires, without building and carrying a full senior clinical organization.
CROs
Therapeutically relevant medical leadership and specialty medical monitoring for studies that need physician depth in the therapeutic area.
Pharmaceutical Companies
Supplemental senior clinical development expertise for programs, periods, or therapeutic areas where internal capacity is stretched.
Founder
David Fineberg, MD, MBA
David Fineberg is a clinical development executive with more than 20 years leading global Phase 1 through Phase 3 drug development. He has held roles from Medical Director through Vice President of Clinical Development, Acting Chief Medical Officer, and Chief Medical Officer, working across biotechnology and pharmaceutical organizations.
He led a global Phase 3 program of approximately 800 patients across 159 sites in 25 countries, with responsibility spanning protocol design, medical monitoring, safety governance, CRO and site oversight, and data interpretation. His regulatory experience includes pre-IND meetings and the negotiation of a potential single-Phase 3 approval pathway.
He currently serves as Medical Director at Sitero, a contract research organization, with medical monitoring responsibilities spanning sepsis, oncology, and metabolic indications, and as an Advisory Board Member at Spectral Medical Inc.
He holds an MD from Tel Aviv University and a Global Executive MBA from UNC Kenan-Flagler Business School. His clinical research has been published in JAMA.
Global Reach
Based in the Research Triangle, experienced across the globe
DF Clinical is headquartered in Cary, North Carolina, in the Research Triangle.
Clinical development experience and professional relationships extend across the United States, Europe, Israel, and Southeast Asia, built through multi region trial conduct, investigator and site engagement, and work with regional clinical research organizations. Engagements are delivered from North Carolina and conducted remotely with travel as a program requires.
Join the Network
For experienced physicians and medical monitors
DF Clinical works with physicians who have substantive clinical trial experience on medical monitoring and safety oversight engagements. If that describes your background, we would be glad to hear from you.
If a program needs senior clinical leadership, the first conversation is a short one.
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.