Fractional Head of Toxicology for IND-bound Biotechs

Embedded nonclinical leadership for Seed–Series B teams without internal toxicology

Transforming Nonclinical Complexity into Confident Drug Development

With a Fractional Head of Toxicology, you get embedded nonclinical leadership from discovery through IND. This includes tailored safety strategy, data integration, and regulatory-ready execution to meet your program’s unique challenges. Whether you need end-to-end toxicology oversight, IND-enabling package design, or expert regulatory authoring, fractional leadership brings the high-touch, senior-level guidance required to move your therapeutic forward with confidence.

WHO IS THIS FOR?

Seed - Series B biotech companies
First or second IND programs
Teams without in-house toxicology leadership
Founders managing CROs without a central nonclinical owner
Teams nearing regulatory interactions without nonclinical leadership

HOW IS THIS DIFFERENT?

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HOW DOES IT WORK?

Fractional Toxicology Leadership (Ownership)

Nonclinical Strategy Audit (Guidance)

Most nonclinical support focuses on execution.
We focus on decision ownership.

That means prioritizing strategy over templates, interpretation over volume, and clarity over late-stage rework.

What this means in practice:

Strategy before studies
We don’t start with templates or checklists. We start with the decisions your program will need to defend - and work backward.

Interpretation, not accumulation
More data does not automatically reduce uncertainty. Clear interpretation does.

Sequencing with intent
Studies are planned and timed to support regulatory and clinical decisions, not just to satisfy requirements.

One point of nonclinical ownership
CROs execute. Internal teams contribute. We own the nonclinical story that connects it all.

Regulatory confidence, not hindsight explanations
Decisions are made deliberately, documented clearly, and aligned to how regulators evaluate risk.

YOUR FRACTIONAL HEAD OF TOX

Dessi McEntee, MS, DABT

Founder, Toxistrategy

Author of Data Is Not Strategy

Download CV

Dessi McEntee is a board-certified toxicologist and fractional Head of Toxicology trusted by early-stage biotechs to provide the senior-level nonclinical leadership they don’t have in-house. With 15+ years of hands-on experience spanning exploratory research through IND-enabling development, she has guided toxicology strategy for small molecules, biologics, nanoparticles, radiopharmaceuticals, and more across oncology, immunology, pain, and rare disease. Her leadership has supported multiple programs advancing to first-in-human studies, and her regulatory track record remains flawless.

Toxistrategy isn’t a large consulting shop—it’s Dessi’s high-touch, embedded model of nonclinical leadership. As your fractional Head of Tox, you gain direct access to a seasoned expert who integrates seamlessly with your team, anticipates challenges before they surface, and delivers clear, actionable strategy. No layers, no handoffs—just focused, senior-level guidance that accelerates your path to the clinic and gives founders the confidence they need to move fast and move smart.

TESTIMONIALS

"I have worked closely with Dessi for many years, both at small molecule and protein biologics companies. What has impressed me the most about her skill sets and experiences is that she is very diligent in not only designing the studies, executing them to the highest standards but she also makes a concerted effort to understand the science behind the programs she has been involved with.

In an area that seems to be changing in the requirements for nonclinical safety and drug development, Dessi is extremely up-to-date on this morphing landscape. This has been comforting for me and my teams in that we know that she will ensure compliance with the changing times.

Even after our times together at the same organizations I continue to reach out and recommend Dessi as my go-to nonclinical colleague. Besides her immense knowledge base in the areas of safety and nonclinical drug development, Dessi is one of the kindest, hard-working individuals I know and would be a benefit to any organization/team. I have worked with Dessi for years and look forward to continuing any opportunity where we can work together again."

Principal Consultant, TranslationalBio LLC

"We have had the pleasure of collaborating with Dessi on several projects spanning multiple therapeutic indications, and her contributions have been consistently outstanding. As a toxicologist, Dessi delivers thorough, well-reasoned insights that not only answer our questions but also provide a clear scientific rationale behind each recommendation.

Her ability to respond quickly and comprehensively has been invaluable to our work, enabling informed decision-making across a diverse portfolio of early drug discovery programs. Dessi’s expertise and professionalism make her an exceptional partner, and we deeply appreciate the clarity and depth she brings to every engagement.

As an Academic Drug Discovery Accelerator supporting projects globally, we rely on collaborators who combine scientific rigor with responsiveness — and Dessi exemplifies exactly that.”

Director, Drug Discovery and Development

"Ringing endorsement right here! Dessi has brought clarity, strong project management, and adherence to timeline, with a clear set of deliverables expectations. But what sets her apart is early and highly contextualized understanding of the program, the study, and the analysis."

VP, Strategic Programs

"It was a pleasure to work with Dessi both as a colleague and manager. Dessi is among the most innovative scientists I’ve known, with broad expertise in molecular techniques, drug discovery, toxicology, SEND datasets, and mechanisms of drug toxicity. She consistently delivered high-quality, well-reviewed data and was instrumental in interpreting results to advance projects.

Dessi’s collaborative approach, reliability, and exceptional time management truly set her apart. She’s an excellent communicator, a quick learner, and a thoughtful leader, blending technical, scientific, business, and interpersonal skills seamlessly. As a manager, she is supportive, fair, and a strong mentor. I highly recommend Dessi as an invaluable leader for any organization."

VP, Head of Toxicology

"I was in the early stages of a GLP tox study for a drug compound I was developing. Dessi was recommended by a friend as a Toxicology consultant. My team had an initial meeting with Dessi and we found her to have an extensive amount of experience in running toxicology studies and she came across as being technically very strong, a good communicator good teamworking skills and gave us a sense that each project she works on she is personally invested in it.

We hired her immediately and found that our initial assessment of her was spot on. Upon starting she immediately reviewed the study protocol and made suggestions to improve the study and study sites to consider which in turn helped us reduce costs. She helped us select a site and worked with the site study director to get the study up and running in no time at all. She maintained constant contact with the study director during the in-life portion of the study to ensure that the study was done properly and stayed on schedule. She also worked closely with the study director to ensure that all planned analysis was done in a timely manner and a high-quality final report was generated.

Overall, we could not have been happier with the guidance and work that Dessi gave us and I highly recommend her to anyone that asks me if I know a great toxicology consultant."

CEO, Biotech

"Dessi is an excellent toxicologist who provides useful and practical guidance related to the development of both large and small molecules. Her extensive knowledge base of compound characteristics, study design and in vivo observations allows her to provide perspective on both how to design toxicology studies and how to interpret the results.

I particularly appreciate her ability to separate “signals” from “noise” allowing companies to determine whether the findings will impact development, whether additional studies are warranted and what a path forward might look like. Her pragmatism is invaluable in executing a successful toxicology program. I highly recommend Dessi to any company needing toxicology input."

Biotech CEO

"I was fortunate to work with Dessi while she consulted for a couple of pre-clinical, small molecule programs. She was able to succinctly summarize recommendations for studies that aligned with company budget and R&D needs to progress the programs. She was also able to adjust studies, plans and work with vendors to make immediate adjustments if plans changed, which is critical for start-ups. She interfaced with other consultants and CROs to ensure a seamless execution of planned studies, and was always a pleasure to work with."