Product Lead, SentinelAgent AI for Clinical Trials

Massive Bio, Inc.; Tennessee; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Massive Bio, Inc. is seeking a Product Lead for SentinelAgent Platform to advance a regulated, clinician‑in‑the‑loop system. You’ll own PRDs, write actionable user stories, and steer releases with QA, design, and data/ML partners across time zones.

You’ll ensure guardrails, data residency, and regulatory alignment throughout development. You will collaborate with engineering in Turkey and sponsor teams, driving a roadmap that enables multi‑sponsor deployment and shadow‑mode validation before

Qualifications

• 6+ years of product management in regulated health software (GxP/21 CFR Part 11).
• Experience shipping PRDs and gate releases with validation behind you.
• Integration literacy with HL7 FHIR, CDISC ODM-XML and CDASH.
• Professional English and sponsor-facing documentation in English.

Responsibilities

• Own the PRD as a living document with user stories and acceptance criteria.
• Groom backlog, write actionable stories, and demo every two weeks.
• Manage cross‑functional work across regional and international teams.
• Ensure regulatory, security, and privacy requirements are met for each release.

Skills

Product management

Regulated health software

PRD ownership

Acceptance criteria

Distributed engineering

English proficiency

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

EDC APIs

ePRO APIs

Job description

Massive Bio, Inc. is seeking a Product Lead for SentinelAgent Platform to advance a regulated, clinician‑in‑the‑loop system. You’ll own PRDs, write actionable user stories, and steer releases with QA, design, and data/ML partners across time zones.

You’ll ensure guardrails, data residency, and regulatory alignment throughout development. You will collaborate with engineering in Turkey and sponsor teams, driving a roadmap that enables multi‑sponsor deployment and shadow‑mode validation before