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.

hellophoto on its way
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.

Follow the line. It starts with patients, runs through the preclinical bench and the clinical trial, and ends with the AI layer that now sits across all of it. Open any stop for the full case study.

OriginUCSF · MGH

It starts at the bedside.

As an oncology research coordinator I consented patients onto CAR-T and immunotherapy trials, chased queries at 7pm on Fridays, and learned exactly what a badly designed eCRF costs a site. I co-authored a molecular biology paper along the way (Jiang et al., 2016). Every product decision since has been a vote for the person entering the data.

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

Vendor cytotoxicity data that scientists hand-normalised became a validated pipeline with QC flags, a one-click IC50 curve generator and a 71-assay automation roadmap.

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

71-assay roadmapQC-flagged, never droppedIC50 in one click
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

Led Vial's entire eClinical stack from a blank repo: five applications, 21 CFR Part 11 end to end, roughly 4.7× cheaper than vendors across five trials.

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

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

Data management, automated — with a human signing off

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

Bi-weekly MedDRA/WHODrug coding, a query-review playbook and version-level eTMF tracking against the DIA model — pipelines instead of a data manager's chores.

The call Automate the chore, keep the human signature.

MedDRA · WHODrugDIA TMF modelBi-weekly, automated
ClinicalVial · program management

Shipping regulated software every two weeks

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

Validation packages signature-ready at merge, a documented hotfix path, and tickets specified tightly enough that a coding agent implements and one engineer reviews.

The call Slower merges, faster trials.

FRS · Trace · OQAgent-built, human-reviewedSignature-ready at merge
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

An agent that reads EDC data and drafts monitoring findings. Catch rate ~60% → ~92% over six iterations; weekly review 8–12h → 2–3h; override rate steady at 11%.

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

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

Regulatory documents drafted from structured program data

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

Investigator's Brochures, Pre-IND packages and protocols drafted from the program database with a shared rubric and modality overlays — writers edit instead of starting from blank.

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

22 canonical prompts16-section Pre-INDsiRNA · mAb · bispecific
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 slides8 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
ic50-curve-generator
Dose-response curves with donor variability
productionReact
deployment-docs
FRS, trace matrix and OQ updated per release
productionClaude
market-intel
Daily biotech briefing, QC-gated, posted to Notion + Slack
productionClaude · n8n
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.

The same instinct — notice a thing that should exist, then make it — pointed at weddings, textiles, poetry and sound.

Side venture

Sour Cherry

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

Etsy line

Printable wedding cards

Bridesmaid and groomsman proposal cards and event welcome signs — mehndi, sangeet, haldi — designed to not look generated.

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.