Product Lead, AI-Driven Clinical Trials Platform

Massive Bio, Inc.; Massachusetts; On-site; USD 140,000 - 210,000; Full time

Job summary

Massive Bio, Inc. seeks a Product Lead for the SentinelAgent Platform to drive a regulated, sponsor-facing product in oncology trials. You’ll own requirements, write user stories, and collaborate with Turkey-based engineers and US teams to deliver secure, compliant software.

You’ll shepherd the platform from pilot to multi-sponsor production, ensuring traceability, QA readiness, and strict data governance across regions while aligning with FDA guidance.

Qualifications

• 6+ years of product management in regulated health software (eClinical, AI in healthcare).
• Owned PRD, acceptance criteria, and shipped releases through validation gates.
• Experience with HL7 FHIR, CDISC ODM/XML, CDASH and EDC/ePRO APIs.
• Knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11, HIPAA and GDPR.
• Ability to lead across time zones with distributed engineering teams; English proficiency.

Responsibilities

• Own the PRD as a living document with personas and user stories.
• Groom backlog, write stories, demo every two weeks, maintain release checklists.
• Scope across modules: ingestion, EMR, EDC, ePRO, dashboards, audit ledger, orchestrator.
• Ensure regulatory and contractual requirements, including audit trails and data residency.
• Drive roadmap gates and validate integrations with sponsor and site teams.

Skills

Product management

Regulated health software

GxP / 21 CFR Part 11

PRD ownership

English proficiency

Cross-functional leadership

API understanding (FHIR/CDISC)

Tools

HL7 FHIR

CDISC ODM/XML

CDASH

EDC APIs

ePRO APIs

Job description

Massive Bio, Inc. seeks a Product Lead for the SentinelAgent Platform to drive a regulated, sponsor-facing product in oncology trials. You’ll own requirements, write user stories, and collaborate with Turkey-based engineers and US teams to deliver secure, compliant software.

You’ll shepherd the platform from pilot to multi-sponsor production, ensuring traceability, QA readiness, and strict data governance across regions while aligning with FDA guidance.