Fractional Chief Medical Officer
A fractional chief medical officer is a physician who holds senior clinical accountability for a program without the company building a permanent full-time CMO seat. DF Clinical provides that leadership for biotechnology and pharmaceutical sponsors, and for CROs that need therapeutically relevant medical direction: development strategy, protocol judgment, medical monitoring oversight, regulatory interactions, and CRO direction, carried by the same person who is responsible for the clinical decisions.
The Decision
A full-time chief medical officer makes sense when clinical leadership is a standing executive seat: a broad pipeline, a board that expects a permanent medical officer, and enough day-to-day volume to fill the role. Many programs are not there. An emerging company may have one asset, a defined registrational question, and a founder or chief executive who needs a physician accountable for clinical decisions without hiring an entire senior clinical organization.
A fractional chief medical officer engagement fits that gap. It also fits a pharmaceutical team that needs senior clinical depth for one program, one period, or one therapeutic area where internal capacity is stretched, and a CRO that needs physician leadership with therapeutic depth rather than a generic staffing layer. The test is whether the program needs named medical accountability now, not whether it can justify a permanent officer.
Scope of Work
The scope is written down at the start: what is decided, what is reviewed, and what is escalated. Medical accountability is then clear to the team, the board, and the CRO.
01
Indication selection, the development pathway, and the clinical plan that connects first-in-human work to a registrational question. The output is a plan a team can execute and a board can examine, including where the assumptions are most likely to fail.
02
Protocol development and critical review: eligibility, endpoints, and whether the study can actually be run. This is the same judgment described under clinical development consulting on the services page. See the clinical development consulting services for the full range of work.
03
Oversight of medical monitoring while a study runs: eligibility and safety decisions, adverse event assessment, and safety governance, including data safety monitoring boards. The day-to-day layer is described under clinical trial medical monitoring.
04
Preparation for FDA interactions, CRO oversight and direction, and enrollment problems diagnosed at the protocol and the site rather than only escalated. See site feasibility and enrollment.
How Engagements Work
An engagement may be a defined piece of work, such as a development plan, a protocol review, or preparation for a regulatory meeting. It may equally be sustained fractional chief medical officer leadership across a program. Duration follows the program, not a template.
Sites and the sponsor deal with a physician who knows the protocol and the program history. David Fineberg, MD, MBA has held roles from Medical Director through Vice President of Clinical Development, Acting Chief Medical Officer, and Chief Medical Officer, and led a global Phase 3 program of approximately 800 patients across 159 sites in 25 countries, including medical monitoring, safety governance, and CRO and site oversight.
If a program needs a permanent full-time chief medical officer, or is at a stage where senior clinical leadership would not change the outcome, DF Clinical will say so. That is a more useful answer than an engagement.
Therapeutic Context
The practice is built around programs that need physician judgment in the therapeutic area, not a generalist overlay. Oncology experience on the site covers solid tumors including metastatic colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer, and modalities that include cancer immunotherapy, allogeneic cell therapy, oncolytic viruses, and targeted small molecules. Adjacent work includes sepsis and coagulopathy, hematology and immunology biologics, and monoclonal antibody programs.
A fractional chief medical officer engagement uses that background where it fits and says so where it does not. See the therapeutic area expertise the network covers.
Common Questions
A fractional chief medical officer is a physician engaged to hold senior clinical accountability for a company or a program without a permanent full-time chief medical officer seat. The work covers development strategy, protocol judgment, oversight of medical monitoring and safety, regulatory interactions, and direction of CROs and clinical vendors. The role is medical. It is not a marketing, commercial, or communications seat.
A full-time chief medical officer is a standing executive, usually across a pipeline and a corporate calendar. A fractional chief medical officer is scoped to the program or the period that needs senior medical accountability, with the decisions, reviews, and escalations written down at the start. The medical standard is the same. The difference is permanence and breadth, not a lighter version of clinical judgment. Companies hire fractional when they need the accountability now and do not yet need, or cannot yet carry, a permanent officer.
No. In biotech and pharma search results the abbreviation CMO is often chief marketing officer. A fractional chief medical officer is a physician responsible for clinical development decisions. DF Clinical does not provide marketing, branding, or commercial leadership. When this site says fractional CMO, it means fractional chief medical officer.
Typical scope includes clinical development strategy, protocol design or critical review, oversight of medical monitoring and safety governance, preparation for FDA interactions, and CRO direction. It can be a defined assignment or sustained leadership. Medical monitoring itself is described on its own page, and site feasibility and enrollment on its own page. The engagement states which of those sit inside the fractional chief medical officer scope and which are separate.
David Fineberg, MD, MBA, founder of DF Clinical. He has more than 20 years in global Phase 1 through Phase 3 drug development, has served as Acting Chief Medical Officer and Chief Medical Officer, and currently serves as Medical Director at Sitero 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. Engagements are led by him and supported, as needed, by the practice's physician network.
To discuss a specific program, describe the program and where it stands. Scheduling a call is a short conversation, not a sales process.
Describe where the program stands and what decision is in front of you. We will tell you plainly whether fractional chief medical officer leadership is the right kind of help.