Fractional Tox Leadership
Without the Full-Time Headcount
Executive-level nonclinical ownership for biotech teams without internal tox that are building fast.
I function as your internal Head of Toxicology — without the full-time salary.
The Problem
Most established yet early biotechs:
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Have no true ownership of nonclinical
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Frequently make fragmented decisions
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Spend millions on CROs
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End up with unstable regulatory narratives
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Leave executive teams exposed and uninformed
The Solution
Our Fractional Head of Tox services:
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Own nonclinical strategy and the risk
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Create stable, streamlined tox development
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Direct and manage CRO execution
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Control regulatory interpretation and interactions
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Align toxicology with investor + FDA expectations
To protect scientific rigor, regulatory precision, and responsiveness, Toxistrategy limits Fractional Toxicology Leadership to a maximum of three concurrent clients at any time.
What You Get
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Global nonclinical strategy ownership
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Reduced regulatory risk
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IND-enabling tox program architecture
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Species and model selection strategy
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CRO alignment & accountability
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Protocol review & optimization
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TK & human dose justification
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Safety interpretation for clinical transition
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IND & regulatory authoring
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Agency interaction and support
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Ongoing founder-level advisory