Product Lead, AI‑Driven Clinical Trials Platform

Massive Bio, Inc.; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

Massive Bio, Inc. is seeking a Product Lead for the SentinelAgent™ Platform to move from early pilots to a validated, multi‑sponsor platform. You will own the PRD, validate risk and requirements, and work with a distributed team across time zones to deliver regulated clinical AI features.

You will oversee the governance gates, ensure compliance with 21 CFR Part 11, and coordinate with sponsors, sites, and QA to ship robust, auditable solutions in global oncology trials.

Qualifications

• 6+ years of product management in regulated health software.
• Experience shipping PRD–driven releases with validation packages.
• Strong integration literacy with HL7/FHIR and ePRO APIs.

Responsibilities

• Own the PRD as a living document with acceptance criteria.
• Groom backlog and write actionable user stories.
• Coordinate with distributed engineering teams and conduct regular reviews.
• Define and validate connectors for clinical platforms (Medidata Rave, Oracle, Veeva).
• Ensure governance: audit trail, data residency, and regulatory compliance.

Skills

PRD ownership

Regulated health software

Cross-functional collaboration

English proficiency

Time-zone coordination

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

ePRO APIs

GAMP 5

Job description

Massive Bio, Inc. is seeking a Product Lead for the SentinelAgent™ Platform to move from early pilots to a validated, multi‑sponsor platform. You will own the PRD, validate risk and requirements, and work with a distributed team across time zones to deliver regulated clinical AI features.

You will oversee the governance gates, ensure compliance with 21 CFR Part 11, and coordinate with sponsors, sites, and QA to ship robust, auditable solutions in global oncology trials.