Fractional CMO Services

A fractional CMO takes responsibility for the clinical direction of a program on an agreed part-time basis. The scope is written down at the start: which decisions we lead, which we advise on, which stay with your executive team, and how much time is reserved each week or month.

Most engagements draw on six areas of responsibility.

• Development strategyOwnership of the clinical development plan: indication and population choices, study sequence, dose and endpoint strategy, and the evidence needed at each financing and regulatory milestone.
• Clinical governanceDecision rights, medical oversight, safety-review arrangements and escalation routes, set up so that clinical questions are answered by someone who is accountable for the answer.
• Team and provider coordinationDirection of clinical operations, data management, biostatistics, medical monitoring, the CRO and outside consultants, so that the protocol, the vendors’ work and your timelines point at the same questions.
• Executive and board contributionClinical content for board meetings, investor diligence and partnering discussions, and a credible clinical voice in the room when the CEO needs one.
• Regulatory and scientific interactionClinical positions for agency meetings, briefing packages and scientific advisory boards, prepared with your regulatory lead.
• Milestone supportConcentrated leadership around a defined inflection point: first-in-human, a data readout, an end-of-phase meeting, a financing or a transaction.

Oncology programs are shaped by a few clinical choices made early: population, dose, endpoint, comparator and sequence. They are hard to reverse once sites are active and data are accruing. Emerging companies often make these choices with a strong science team and a thin clinical bench.

A fractional CMO puts a senior clinical decision-maker beside those choices at a cost that fits the company’s stage. The model also works for companies between permanent hires, and for those that want an experienced second view while a new CMO settles in.

• Before the first senior clinical hireThere is a plan and a pipeline, but nobody senior owns the clinical decisions.
• Ahead of a financing or board decisionThe development plan has to stand up to investor and board scrutiny.
• During a leadership gap or transitionA CMO has left, is about to join, or is stretched across too many programs.
• When the program changes shapeA new indication, a combination, a dose-optimization question or a move toward a registrational design.

1. Agree the mandate We define scope, decision rights, time commitment, reporting line and the interfaces with your regulatory, CMC, operations and finance leads. Conflicts and availability are confirmed before work begins.
2. Take stock quickly A structured read of the plan, protocols, vendor arrangements, data to date and open issues, ending in a short list of the decisions that matter most over the next six to twelve months.
3. Lead the agreed decisions Regular working sessions with your leadership, written positions on the questions that need one, and direct participation in vendor, investigator and advisory-board discussions as scoped.
4. Leave the company stronger Documented decisions, working governance routines and, if wanted, a role profile and handover plan for a permanent appointment.

• A written assessment of the development plan and a prioritized decision agenda
• Clinical positions and decision memoranda on the questions we lead
• Governance documents: decision rights, escalation routes and medical-review arrangements
• Board, investor and partner materials covering the clinical program, within scope
• A recruitment and transition brief if the role is to become permanent

• StructureA fixed monthly time commitment, a milestone-based project, or a combination, for example heavier involvement around protocol finalization or a readout and lighter between them.
• Title and authoritySome companies want an officer title for investors or regulators; others do not. Whether an engagement includes a formal title is assessed case by case, with availability and conflicts, before it is agreed.
• LimitsFractional leadership does not mean round-the-clock coverage or emergency medical monitoring. Where continuous safety or medical-monitoring cover is needed, it is agreed explicitly and resourced separately. Responsibilities that belong to the sponsor stay with the sponsor.
• What we need from youThe current plan and key documents, access to the people who own CMC, regulatory, operations and finance decisions, and a named executive sponsor.