Want a nonclinical program that will clear your IND?

Your Fractional Chief Development Officer.

With a toxicologist’s depth and an investor’s instincts.

With a Fractional Chief Development Officer, you gain embedded, senior development leadership across the full arc of your program — from early discovery decisions through IND submission and into the clinic.

This role goes beyond advice. It means owning your nonclinical strategy end to end, executing studies with precision, authoring INDs built on defensible interpretation, and making sure every development decision holds up twice: under FDA scrutiny, and the day an investor opens your data room.

Whether your program needs end-to-end development oversight, IND-enabling study design, hands-on CRO leadership, regulatory ownership, or a development story that funds your next round, fractional leadership gives you the same ownership and accountability expected of a full-time Chief Development Officer — without the full-time hire.

I’ve sat in every seat that decides your program’s fate.

Most people you'd hire have done one of these jobs. I've done them all.

The lab seat. Board-certified toxicologist (DABT), 15+ years from discovery through IND-enabling development — small molecules, biologics, nanoparticles, radiopharmaceuticals — across oncology, immunology, pain, and rare disease. Multiple programs advanced to first-in-human. Regulatory record: clean.

The Founder seat. I've built and run my own venture — raised on the strength of the science, filed the patents, wrote the SBIR application, owned the equity structure and the strategy. I know what it's like when the program is the company.

The operating seat. I work as a fractional Chief Development Officer — currently the acting CDO at Immugen BioPharma. Not advising from the outside, doing the job, live, right now.

The cap table. I run diligence for VCs evaluating biotech deals. I know exactly what an investor pulls apart in your data room, because I'm the one they pay to pull it apart.

The boardroom. Biotech board member. I've made go/no-go calls from the governance seat — not just recommended them.

The classroom. Founder of Nonclinical Academy and author of Data Is Not Strategy. Thousands of scientists read my work every week. The whole job there is turning complex science into something anyone can follow — the same skill that gets your program funded by people who aren't scientists.

Operator, founder, evaluator, director, educator. Your program never hits a seat I haven't already sat in.

Here's what winning looks like.

An IND the FDA clears. A round that closes because your program held up the moment investors opened the data room. A molecule that keeps moving toward the clinic — instead of stalling in the gap that sinks most early-stage biotechs.

That’s where you’re headed, and I’m how you get there.

I take development off your plate and carry your program to IND — built from day one to survive the diligence that funds your next round. I make sure the science, the regulatory path, and the investor story all hold up.

IND-defensible. Investor-fundable. That’s what you walk away with.

Talk to Dessi

YOUR FRACTIONAL CDO

Dessi McEntee, MS, DABT

Founder, Toxistrategy

Author of Data Is Not Strategy

Download CV

Dessi McEntee is a board-certified toxicologist and fractional Chief Development Officer trusted by early-stage biotechs to own the senior-level development leadership they don't have in-house. With 15+ years of hands-on experience spanning exploratory research through IND-enabling development and into the clinic, she has led programs across small molecules, biologics, nanoparticles, radiopharmaceuticals, and more — in oncology, immunology, pain, and rare disease. Her leadership has carried multiple programs into first-in-human studies, and her regulatory track record remains flawless. Having sat on the diligence side of the table for VCs and in the founder's chair herself, she builds programs that hold up under FDA scrutiny and in the data room alike.

Toxistrategy isn't a large consulting shop — it's Dessi's high-touch, embedded model of development leadership. As your fractional CDO, you gain direct access to a seasoned expert who owns your nonclinical strategy end to end, integrates seamlessly with your team, anticipates challenges before they surface, and translates complex science into a story your board and investors can act on. No layers, no handoffs — just focused, senior-level ownership that accelerates your path to the clinic and gives founders the confidence 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."