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Fractional Head of Toxicology

for early-stage Biotechs

End‑to‑end nonclinical ownership and execution,
from first tox decisions through IND

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Lab Pipettes Closeup

End-to-End Nonclinical Ownership and Execution, Without the Full-Time Hire

With a Fractional Head of Toxicology, you gain embedded, senior nonclinical leadership across the full arc of development, from early discovery decisions through IND submission.

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This role goes beyond advice. It means owning toxicology strategy, executing studies with precision, authoring IND's through defensible stories, and ensuring every nonclinical decision supports a strong regulatory narrative.

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Whether your program needs end-to-end toxicology oversight, IND-enabling study design, hands-on CRO leadership, or regulatory ownership, fractional leadership provides the same ownership and accountability expected of an internal Head of Toxicology, without the commitment of a full-time hire.

WHO IS THIS FOR?

Chess

​Fractional Tox Support might be a great fit if...

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  • You’re moving toward IND, but don’t yet have internal toxicology ownership

  • Nonclinical decisions are already shaping timelines and budgets, even without a Head of Tox

  • CSOs and R&D leads are managing CROs directly, without toxicology leadership

  • Regulatory interactions are approaching, and no one owns the nonclinical story end-to-end

  • You need someone who can own your tox strategy but also execute the studies and author the IND

HOW IS THIS DIFFERENT?

HOW DOES IT WORK?

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Nonclinical work is often split across vendors and consultants.

 

Fractional support delivers one accountable toxicology lead responsible for strategy, study execution, interpretation, and IND-ready output.

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What this means in practice: 

Lab Mouse Held

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

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  • Interpretation, not accumulation
    I make explicit calls on adversity, exposure relevance, and decision impact, so existing data reduces uncertainty instead of triggering additional studies.

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  • Sequencing with intent
    Studies are designed and executed to support regulatory and clinical decisions, not just to satisfy requirements.​​

  • One point of nonclinical execution
    CROs run the studies and internal teams contribute, but I actively execute and oversee the nonclinical work that connects it all.

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  • Regulatory ownership and authoring
    Nonclinical decisions are made deliberately and delivered through defensible regulatory strategy and authoring.

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YOUR FRACTIONAL HEAD OF TOX

Dessi McEntee, MS, DABT

Founder, Toxistrategy

Author of Data Is Not Strategy

  • LinkedIn

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.

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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.

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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."

Director, Business Development

"I highly recommend Dessi to any company needing toxicology support."

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