Engagement · Primary Structure

Fractional CMO for AI-oncology and biotech companies

A senior oncology Chief Medical Officer, embedded with one company on the decision arc that determines whether the molecule reaches the next phase — without the cost and calendar of a full-time CMO hire you may not yet need.

What a Fractional CMO Is

The senior clinical-regulatory seat, at the fraction of time your stage actually requires.

A fractional Chief Medical Officer is a senior physician-executive who leads the clinical and regulatory strategy of a company part-time, on a contract basis. For an early-stage oncology company, that means the person who owns the eight to twelve decisions in front of the program — endpoint, indication, trial design, and the FDA interactions that gate the next phase — is in the room now, rather than after a nine-month executive search or not at all.

The structure is built for a specific moment: a funded early-stage oncology company — AI-originated or conventional — that has not yet hired its full-time CMO and has a pre-IND or Phase I decision arc immediately in front of it. Embedded with one company, agenda set by the near-term FDA decision arc, for a six-to-eighteen-month commitment. It is priced for reserved capacity and accountability — a defined weekly commitment, named decision rights, a fixed term — on a cash basis, with equity added selectively where the situation warrants it.

A fractional role retires near-term decision risk. It does not build a long-term clinical-regulatory function on the calendar required to build one. If what your company needs is a culture, you need a different hire, on a different clock.

What the Role Covers

Senior judgment on the decisions that determine whether the molecule reaches Phase II.

• Endpoint and design strategy the FDA can actually review — translating AI-discovered targets and prioritized candidates into endpoint structures, trial designs, and pre-IND positions the agency has precedent to accept; and, where the science calls for it, proposing a reasoned departure — accelerated approval on early response, a novel surrogate, a tumor-agnostic indication, an external control — on terms the agency can engage with.
• Trial designs that enroll — pressure-testing inclusion/exclusion logic, referral patterns, line-of-therapy windows, and combination-regimen practicality against what community oncologists will actually prescribe, before the protocol is locked.
• Indication and population choice — where the first program should be aimed, and what the evidence will and will not support.
• Regulatory translation — putting the science into the language and documentation tier a CDER review division will accept, so the engineering that already exists is legible to the reviewer.
• Representing the clinical-regulatory story — to the board, to investors, and in the pre-IND and first-in-human interactions themselves.

Who It's For

You and I will be a fit if:

• Your program is pre-IND or in Phase I, and funded to act on the decisions in front of it — whether the science is AI-originated or conventional.
• Your team is strong on the science — and on computation, where the program is AI-originated — and already sees clinical-regulatory judgment as the next seat to fill, not the last.
• The decisions in front of you in the next 90 to 180 days are real, and your program turns on them: endpoint strategy, trial design, FDA interactions, indication choice.
• You want reserved senior capacity with real decision rights and direct accountability — a structure shaped to the scope, not a name on the deck.

The fractional CMO structure is a small number of companies, deep involvement, and accountability for the outcomes that determine whether the molecule lives or dies — priced for the capacity it reserves and the decisions it retires. What it is not is the retainer: the name on the deck, the board-call contract, the open-ended claim on the calendar that produces nothing a more junior advisor could not.