Expert role · CMO / VP R&D
The go/no-go memo, with the case for both answers.
A decision-gate memo drafted from the verdict, the valuation scenarios and the operational risk — including the evidence that argues against the recommendation. The call stays yours; the preparation for it does not have to be.
One gate, two documented exits.
The job · the CMO or VP of R&D who has to make the call and defend it later
You own the decision. The memo behind it takes a week you do not have.
A decision gate is only as good as the memo that goes into it. The recommendation is the easy part; what makes the gate defensible six months later is the record of what was known at the time — which comparable programmes failed and why, what the valuation looked like under a pessimistic probability of success, and which operational risks were already visible.
This workspace assembles that record and drafts the memo from it, including the counter-case. The valuation scenarios recompute when the underlying assumptions move, so the memo you sign is the memo the evidence supported on the day you signed it — and if that evidence later changes, the signature is flagged rather than quietly left standing.
What it covers
- Author decision-gate memos for the go/no-go call
- Compute and model risk-adjusted valuation (eNPV) scenarios
- Frame readout risk and the evidence that argues against the recommendation
- Roll individual study reads up into a portfolio view
In the role registry
Portfolio eNPV, decision-gate memos, readout-risk framing
What it drafts
Deliverables — drafts, until signed.
Each artefact arrives with its citations attached and its status explicit. Nothing below is final until a named human signs it.
Go/No-Go decision-gate memo
The recommendation, the reasoning, and the evidence that cuts the other way — drafted so the gate has a written record of what was known when the decision was taken.
Signed off by
the CMO or VP R&D who owns the gate
eNPV scenario set
Risk-adjusted valuation under a set of scenarios, recomputed when the probability-of-success or pricing assumptions move, so the memo never carries a stale number.
Signed off by
the CMO with the commercial lead
Readout-risk framing
What could still change the answer between now and the readout — drawn from the operational-risk dashboard, adverse-event signals and sponsor delay signals in public filings.
Signed off by
the CMO or VP R&D
Portfolio brief
Individual study reads rolled up so a gate on one asset can be argued in the context of the others competing for the same budget.
Signed off by
the CMO or VP R&D
What it reads
It drafts from the assessment, not from memory
The role has no private knowledge. Every claim it writes traces to an analysis in one of the six pillars, and through that to a public source record.
Verdict
The whole verdict pillar is the memo's spine — the recommendation and, just as importantly, the risks that qualify it.
Commercial
A gate decision is a capital-allocation decision. The valuation has to be in the memo, not in a separate deck.
Design
The most useful thing in a go/no-go memo is often what happened to the last three programmes that tried this.
Where & How
The cost of running it is half of the go/no-go, and it is the half that is usually estimated last.
How it is governed
A role drafts. A human signs.
This is the part that matters, so it is stated without hedging: the role has no authority to approve anything, and its output has no standing until a qualified person puts their name on it.
The role drafts.
It produces a draft deliverable with its citations attached. A draft has no standing: it is not approved, not final, and not actionable. The role has no authority to change it into any of those things.
A named human reviews.
The draft lands as a task for a specific person on your team. They can edit it, reject it, or send it back for a re-draft against the current evidence. Nothing moves until someone with a name has read it.
Sign-off is a Part 11 electronic signature.
Approval is recorded as a 21 CFR Part 11 electronic signature — attributable to an authenticated identity, time-stamped, and bound to the exact version of the record that was signed.
The whole chain is hash-chained.
Every draft, edit, review and signature is appended to a tamper-evident, hash-chained audit trail. It is reproducible and exportable, so your QA team can reconstruct who approved what, on what evidence, and when.
Stale approvals are flagged.
If the underlying evidence later changes, the signed decision is automatically flagged for re-review. Nothing stays approved on data that has since moved.
This role does not replace a qualified medical or R&D executive.
It is a drafting assistant working under human review. It is not an autonomous agent, it does not make regulatory decisions, and its drafts carry no regulatory standing of their own — the signature does.
Where it goes next
The signed record is the hand-off
Roles do not message each other informally. One role's signed output is the next role's input, which is why the chain can be replayed.
The rest of the team
Seven roles, one governed record
Protocol Design
Drafts the trial protocol synopsis from the verdict, design, and cohort analyses — every claim cited.
Commercial Strategy
Market size, standard of care, value-based price, patent runway, and risk-adjusted valuation scenarios.
Biostatistician
Statistical analysis plans, sample-size estimates, and data-monitoring-board materials.
Clinical Pharmacologist
Dose-selection memos, exposure–response modelling, and drug-interaction risk.
Study Start-up
Country activation tracking and contract groundwork for the sites the assessment ranked.
CRO Commercial
Bid-pipeline and portfolio views for CRO business development teams.
See a verdict you can actually check.
Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.