What does a fractional R&D leader actually do?

A fractional R&D leader is a part-time chief scientific or development officer embedded in a company for a fixed share of each week. Unlike a consultant, the role owns program decisions: the development plan, the CRO and consultant network, the regulatory strategy, and the interpretation of the data. The company gets senior accountability without a full-time executive salary, with real limits on availability.

How is a fractional R&D leader different from a consultant or an advisory board member?

A consultant delivers a defined work product: a gap analysis, a draft IND module, a toxicology study design. An advisory board member offers opinions a few times a year with no accountability for outcomes. A fractional leader attends the weekly program meetings, signs off on decisions, and answers for the results when the data arrive.

I have worked in this model from both sides. On the program that carried a first-in-class biologic for a rare pediatric leukemia to IND acceptance, Fast Track designation two months later, and first-in-human Phase 1 trials, the core team was a handful of people. Manufacturing, and toxicology were contracted out, including some more complex bench work. Scientific direction, CRO oversight, and regulatory ownership were not.

What does a fractional leader's week actually look like?

The first block of the week belongs to the vendors. I take the CRO, CDMO, and bioanalytical lab calls, read raw data rather than summary slides, and log every decision. In my experience, vendor problems surface in raw data two to four weeks before they appear in a status report, if someone qualified is reading it.

The second block is regulatory and written work: IND sections, briefing packages, responses to FDA questions, grant aims. FDA's 2026 meetings guidance schedules Type B meetings such as pre-IND within 60 days of the request and end-of-phase meetings within 70 days, with minutes issued within 30 days after the meeting [1]. Someone must own that calendar and that package. The remaining time goes to the founder and board: budget, target product profile, investor diligence, and hiring.

Which decisions does a fractional leader own, share, or only advise on?

The rule I apply is simple. I own the technical decisions whose consequences I can see in the data and reverse if wrong. I share the decisions that commit the company's money. I advise on corporate decisions that belong to those who carry the equity and legal duty. Decision rights that are not written down default to whoever is loudest in the meeting, so I ask for this table to be part of the engagement letter.

Who is legally responsible when the leader is part time?

The regulation does not recognize a fractional role. Under 21 CFR 312.3 the sponsor is the person who takes responsibility for and initiates a clinical investigation, and that is almost always the company, not an individual [2]. The sponsor must select qualified investigators, ensure proper monitoring, keep the IND effective, and promptly report significant new risks to FDA and investigators [3].

A sponsor may transfer any or all of these obligations to a contract research organization, but only in writing, and any obligation not described in the written transfer stays with the sponsor [4]. A fractional leader verifies that each transferred duty is performed. The duty itself never leaves the company, so I treat my own limited hours as a risk to manage, with a named deputy for safety communications and a shared decision log.

Can a fractional leader be the principal investigator on an SBIR or STTR grant?

Usually not on an SBIR. NIH requires that the contact principal investigator's primary employment be with the small business, defined as more than one half of the person's time, at the time of award and throughout the project [5]. Deviations need written approval from the awarding institute and are extremely rare for Phase II [5].

STTR is different. For Phase I and Phase II STTR projects the principal investigator is not required to be employed by the small business and needs only a formal appointment with, or commitment to, the company [5]. In return, a nonprofit research institution must perform at least 30% of the work and the small business at least 40% [6].

The amounts justify settling this early. NIH lists Phase I budgets of $323,090 over six months to two years and Phase II budgets of $2,153,927 over one to three years, and SBIR allows outsourcing of up to 33% of Phase I and 50% of Phase II work [6]. Across more than $25M in non-dilutive funding and in-kind support I have helped secure, the PI question was settled before the first aim was written.

When does a fractional leader stop being enough?

In my experience the breaking point is Phase 2, or the moment a company runs more than two active programs. Phase 2 brings multiple sites, continuous safety reporting, and decisions that arrive daily rather than weekly. A leader available two days a week becomes the bottleneck, and the honest response is to convert the role to full time.

Small core teams can carry a surprising load, but the evidence comes from full-time staff. Schuhmacher and colleagues define virtual R&D as an organization with limited internal staff that uses external resources on demand, and cite one such unit that ran 15 to 17 projects with roughly 40 employees and about 75% of its budget spent externally [7]. That is under three employees per program, with people present every day.

The demand is structural. IQVIA reported in 2022 that emerging biopharma companies accounted for a record 65% of pipeline molecules without a larger company involved and 42% of products filed with FDA, up from 11% in 2012 [8]. Few of these companies can afford a full executive team when the development plan is set. The limits are real, though: a fractional leader will sometimes be the last to hear about a problem.

How should the engagement be structured?

Four items belong in writing before the first week: scope, time, decision rights, and exit. Scope names the programs and the deliverables outside the retainer. Time states the days per week and the response expectation for urgent safety matters. Decision rights are the table above. Exit defines the trigger for conversion to full time and who inherits the decision log, because institutional memory otherwise leaves with the person.

This article is part of the Product Development Services practice at Hamilton Atlas Group — see the full capability list there.

References

1. U.S. Food and Drug Administration. Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products. FDA, 2026.
2. Legal Information Institute, Cornell Law School. 21 CFR § 312.3 - Definitions and interpretations. Electronic Code of Federal Regulations, 2025.
3. Legal Information Institute, Cornell Law School. 21 CFR § 312.50 - General responsibilities of sponsors. Electronic Code of Federal Regulations, 2025.
4. Legal Information Institute, Cornell Law School. 21 CFR § 312.52 - Transfer of obligations to a contract research organization. Electronic Code of Federal Regulations, 2025.
5. National Institutes of Health. 18.5.2 Eligibility. NIH Grants Policy Statement, 2025.
6. National Institutes of Health, SEED. Understanding SBIR and STTR. NIH, 2025.
7. Schuhmacher A, Gassmann O, Hinder M. Changing R&D models in research-based pharmaceutical companies. Journal of Translational Medicine. 2016;14:105.
8. IQVIA Institute for Human Data Science. Emerging Biopharma's Contribution to Innovation. IQVIA, 2022.