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Fractional Tox Leadership

Embedded nonclinical leadership without the full-time salary

If you need a tox program that will clear your IND, let's talk. 

Dessi McEntee Headshot.png

Un-owned
nonclinical programs create downstream regulatory risk

A Fractional Head of Tox is not advisory support layered on top of execution.


It is decision ownership intertwined with execution inside your program.

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I function as part of your internal team - accountable for nonclinical strategy, interpretation, execution, and regulatory narrative from discovery through IND.

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This role exists so that: 

  • Sponsors can own their tox without breaking their budgets

  • Nonclinical programs can have continuity through IND

  • Studies can be executed with confidence and defensibility

When this makes sense:

This model is designed for teams who:

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  • Are IND-bound or approaching key regulatory milestones

  • Have CRO support, but no senior nonclinical owner

  • Are making decisions that will be difficult to unwind later

  • Need continuity across studies, including strategy and execution

 

If your program is moving quickly, uncertainty compounds without leadership.

What I'm accountable for:

As Fractional Head of Toxicology, I own:

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  • Nonclinical strategy and execution

  • Interpretation of nonclinical, toxicology and TK data

  • Alignment between nonclinical data and clinical intent

  • Regulatory narrative and risk posture

  • Cross-functional nonclinical decision-making

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Some do ownership, some do execution. 

I do both. 

Why this is not consulting:

This is not:​

  • ad hoc advice by the hour

  • study-by-study review

  • CRO oversight after the fact

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This is:​

  • ongoing program ownership

  • continuity across studies 

  • a single point of accountability

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I'm responsible for decisions the data are meant to support, not just the data itself.

Business Discussion

What You Get

  • Global nonclinical strategy ownership

  • IND-enabling tox program architecture

  • Species and model selection strategy

  • CRO alignment & accountability

  • Protocol review & optimization

  • TK & human dose justification

  • Safety interpretation for clinical transition

  • IND & regulatory strategic review

  • Agency interaction and support

Engagement Structure

Engagements are structured as a monthly retainer with an initial 3-month commitment to ensure continuity through critical nonclinical decisions.

  • Starting at $6,000 monthly retainer

  • Includes both ownership and execution

  • Initial 3-month commitment

  • Month-to-month thereafter

  • 30-day termination after month 3

To ensure high quality ownership, Fractional Toxicology support is limited to a maximum of three clients at any time.

If you need experienced nonclinical leadership but aren’t ready for a full-time Head of Toxicology, let's talk.

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