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toxicologist

end-to-end nonclinical ownership

without the full-time hire

Fractional Toxicology leadership to keep your IND on track

Fractional Tox leadership catches regulatory risk while it's still cheap

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.

Choose Your Level of Support

Fractional toxicology leadership is structured in tiers based on where you are in development. Each tier includes strategic ownership plus the execution services your program needs at that stage.

DISCOVERY TIER | $3K-$5K per month

Early nonclinical strategy for programs that haven't started toxicology studies yet

Early nonclinical strategy, CRO selection, study planning, budget and timeline insights, and strategic guidance to set your program up for a defensible IND narrative.

DC-ENABLING TIER | $6K-$10K per month

Active strategy and study execution for programs running non-GLP studies

IND-anchored nonclinical strategy, non-GLP study management, data interpretation, report authoring, pIND preparation and GLP study design.

IND-ENABLING TIER | $12K-$14K per month

Full execution for programs running GLP studies or preparing IND

Complete GLP oversight, clinical translation, IND authoring, regulatory strategy, regulatory interactions, and embedded leadership through submission.

All tiers include:

Unlimited strategic consultation, regular check-ins, CRO oversight, and cross-functional collaboration.

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Flexible commitment:

Monthly agreements with 30-day notice. Scale up or down as your program evolves.

Ready to discuss fractional toxicology support for your program?

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