VP of Product · Vial · clinician-builder

Founding product hire at Vial, APM to VP in four years. Built the eClinical platform from zero — EDC, RTSM, portals — for patients, sites and monitors, then the AI tooling that runs on top of it. Before that: oncology research coordinator on CAR-T and immunotherapy trials at UCSF and MGH.

Dhruba Biswas
Currently · VP Product at Vial
🩺 bedside → build
APM → VPin four years, as the founding product hire
5 appsshipped 0→1: EDC, RTSM, Start-Up, Monitoring, Admin
60 → 92%first-pass catch rate for the AI clinical monitor
20+AI skills and pipelines in daily production use
What kind of PM am I?

The kind who asks the uncomfortable question first — usually of myself.

01

It's how you communicate 90% of the time that matters.

The 4pm Slack reply, the ticket, the tradeoff explained to a coordinator — that is what people experience of a PM. I write clearly, early, and to whoever has to act.

02

Does everything I do meaningfully support the business?

The question I ask most, and the easiest to avoid. If the honest answer is a shrug, I stop, say so, and redirect the effort.

03

First principles, so that answer stays honest.

Reason from what the trial, the site or the company actually needs — not from the roadmap, and not from what a vendor happens to do.

The story · bench → bedside → build

One path through the pipeline, told in the products.

OriginUCSF · MGH

It starts at the bedside.

Oncology research coordinator on CAR-T and immunotherapy trials: consenting patients, chasing queries at 7pm on Fridays, learning exactly what a badly designed eCRF costs a site. Every product decision since has been a vote for the person entering the data. Underneath every title since is the same commitment: changing how core healthcare is delivered, industry-wide. It is the work I have given my life to, and the work I intend to keep giving it to.

CAR-T & immunotherapy trialsHeme-Onc
01
Chapter 01

Nonclinical — the bench

Before a drug reaches a patient it generates thousands of assay rows nobody has time to clean.

02
Chapter 02

Clinical — the trial

The part of the pipeline where the software is regulated, the people are tired, and every field has a reason.

03
Chapter 03

AI tooling — the layer

AI that touches trial data has to earn it. Mine keeps a human in the loop until it does.

OriginUCSF · MGH

It starts at the bedside.

Oncology research coordinator on CAR-T and immunotherapy trials: consenting patients, chasing queries at 7pm on Fridays, learning exactly what a badly designed eCRF costs a site. Every product decision since has been a vote for the person entering the data. Underneath every title since is the same commitment: changing how core healthcare is delivered, industry-wide. It is the work I have given my life to, and the work I intend to keep giving it to.

CAR-T & immunotherapy trialsHeme-OncJiang 2016
01
Chapter 01

Nonclinical — the bench

Before a drug reaches a patient it generates thousands of assay rows nobody has time to clean.

NonclinicalVial · drug development

From CDMO spreadsheets to decision-ready curves

Assay data pipelines · IC50 tooling · lab-data ingestion

The call Flag, don't fix — the pipeline surfaces, the scientist decides.

71-assay roadmapQC-flagged, never droppedIC50 in one click
→Read the case study
02
Chapter 02

Clinical — the trial

The part of the pipeline where the software is regulated, the people are tired, and every field has a reason.

ClinicalVial · 2022 →

EDC 0→1: a Part 11–compliant eClinical platform, built in-house

EDC · RTSM · Study Start-Up · Monitoring · Admin — product, engineering, design, research

The call Build, not buy — but only what had to be ours.

21 CFR Part 11~4.7× vs vendors5 apps, 0→1
→Read the case study
ClinicalVial · data management

Data management, automated — with a human signing off

Medical coding · query review · AE/labs reconciliation · eTMF tracking

The call Automate the chore, keep the human signature.

MedDRA · WHODrugDIA TMF modelBi-weekly, automated
→Read the case study
ClinicalVial · program management

Shipping regulated software every two weeks

Release management · validation packages · hotfix process · agent-driven delivery

The call Slower merges, faster trials.

FRS · Trace · OQAgent-built, human-reviewedSignature-ready at merge
→Read the case study
03
Chapter 03

AI tooling — the layer

AI that touches trial data has to earn it. Mine keeps a human in the loop until it does.

AI toolingVial · AI product

AI Clinical Monitor: data review a monitor actually trusts

AI remote data review · prompt iteration · override tracking · human-in-the-loop design

The call Tuned for misses, not noise — decision support, not decisions.

60% → 92% catch rate8–12h → 2–3h / week11% override rate
→Read the case study
AI toolingVial · AI product

Regulatory documents drafted from structured program data

IB generator · Pre-IND packages · protocol & patent drafting · 20+ skills

The call Drafts you can argue with, not documents you have to trust.

22 canonical prompts16-section Pre-INDsiRNA · mAb · bispecific
→Read the case study
How I work

Forward-deployed, by default.

I don't hand problems to a backlog. I sit with the coordinators and monitors, then build — and most of what I build runs in production the same month.

01

Forward-deployed.

I sit in the standup, read the queries, and ship the fix that week. The roadmap is written in the site's problems, not in a slide.

02

Human-in-the-loop until earned.

Regulated AI starts assistive. Override rate is a feature, and autonomy is something a system graduates into with evidence.

03

Spec it so an agent can build it.

A ticket precise enough for an AI agent to implement is a ticket precise enough for anyone. One engineer reviews; the team's hours go to judgement.

04

Validation is product.

The release isn't done until the package is signature-ready. Documentation that lags the code is a bug.

build log · things I shipped, not slides6 tools
clinical-monitor
AI remote data review over EDC data
productionClaude · Metabase
medical-coding-automation
Bi-weekly MedDRA / WHODrug pipeline
productionn8n · coding APIs
ib-generator
22-prompt Investigator's Brochure drafting
productionNotion · n8n · LLM
pind-generation
16-section Pre-IND meeting packages
productionClaude · Google Docs
pbmc-assay-processing
CDMO assay files → QC-flagged, Scispot-ready
productionPython · Notion
deployment-docs
FRS, trace matrix and OQ updated per release
productionClaude
Open-sourcing the non-proprietary pieces. Repos landing here as they're cleaned up.GitHub · coming soon
Hands on, myself:SQL — I pull my own data (Metabase, Postgres)Python data pipelinesReact prototypesn8n automationsClaude skills & agentsFigma → FramerLinear, written like a spec

A Tuesday, with AI.

How it actually shows up in a day — not a strategy, a habit.

A skill has already posted the daily market briefing to Notion. I read it; I didn't write it.

Standup. Two tickets specified tightly enough that a coding agent implements them; one engineer reviews by lunch.

A question comes up about enrolment. I write the SQL myself in Metabase and answer it in the thread, with the chart.

The clinical monitor has drafted this week's findings from the EDC. I review the overrides, not the records.

Prototype a new payment-milestone flow in an afternoon with Claude. The screenshot goes to ops and design to decide, not to debate.

Draft the weekly readout from Linear and the deployment log with a skill. I edit the judgement, then ship it.

AI drafts. I decide. Anything regulated keeps a human signature.
Off the clock

Personal projects, mostly handmade.

Side venture

Sour Cherry

A gifting brand for Indian weddings and festivals — welcome bags first, Holi and Diwali next.

Textiles

Brishti

Silk headscarves. Monsoon-named.

Poetry

Sunday Morning Tabla

A collection, written in the long shadow of Tagore and Rumi.

Suno · Ableton

Generative music

Experiments in letting a model hum and a human arrange.

Let's build something regulated and delightful.

Open to Director / Head / VP of Product roles in clinical-trial tech, eClinical, digital health and life-sciences tooling. Remote US, NYC or the Bay Area.

© 2026 Dhruba Biswas · built by hand.Bench → bedside → build.