Product Lead for AI-Powered Clinical Trials Platform

Massive Bio, Inc.

Indiana

On-site

USD 140,000 - 200,000

Full time

7 days ago

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Job summary

Massive Bio, Inc. is seeking a Product Lead to drive the SentinelAgent™ platform from pilot to a validated, multi‑sponsor tool.

You will own PRDs, manage regulatory requirements, and collaborate with a global engineering team to deliver end‑to‑end solutions for trial data integration and regulatory compliance. You will work with the Chief Medical AI Officer and partners across commercial and clinical operations, ensuring traceability, governance, and security as you scale the platform across

Qualifications

Must have 6+ years of product management in regulated health software (GxP/21 CFR Part 11).
Owned PRD and release gates with validation package and acceptance criteria.
Integration literacy: HL7 FHIR, CDISC ODM-XML and CDASH.
Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and GDPR.
AI/ML product experience under a locked-model regime.

Responsibilities

Own the PRD as a living document with personas and acceptance criteria.
Groom backlog and write stories for engineers to build without meetings.
Coordinate with distributed teams across time zones and manage gate-reviewed releases.
Define connector requirements and acceptance criteria for major platforms (Rave, Oracle, Veeva Vault).
Drive roadmap gates including protocol import, connectors, ePRO, localization and security attestations.
Ensure regulatory-facing product work and audit trails meet 21 CFR Part 11 expectations.