FRACTIONAL CMO & MEDICAL LEADERSHIP

Senior medical ownership without unnecessary fixed overhead

For companies that need accountable CMO-level judgment before they need, or can justify, a permanent full-time structure.

The problem

Critical decisions are being made without one medical owner

The program may be at an inflection point, the board may lack a clear clinical risk view, or functions and vendors may be operating without one accountable development logic. Advice is available, but ownership is fragmented.

What we do

Take accountable ownership of the clinical logic

Clinical development strategy and medical governance
Protocol, endpoint, estimand and evidence decisions
Regulatory preparation and agency interaction support
Board, investor and partner communication
Vendor, safety and execution oversight
Risk escalation and integration of Medical Affairs and payer evidence

Best fit

Use this mandate when senior continuity matters

A biotech is approaching a decisive Phase II or Phase III transition.
A permanent CMO hire would be premature or unnecessarily rigid.
The board needs an independent, board-ready clinical risk view.
Medical, regulatory, operations and external vendors need one decision owner.
A program needs repair without adding another layer of advisory commentary.

Connect leadership to design and execution

A decision-grade next step

Give the clinical program a senior owner.

Define the decision rights, cadence and level of accountability the mandate requires.