Product Lead, AI-Driven Clinical Trial Platform

Massive Bio, Inc.

Virginia

On-site

USD 150,000 - 210,000

Full time

6 days ago

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Job summary

Massive Bio, Inc. is seeking a Product Lead for the SentinelAgent platform to advance a multi-sponsor, regulatory-compliant solution that coordinates protocol ingestion, EDC/EMC connectors, and clinical workflows.

You will drive backlog, write actionable stories, and ensure rigorous validation with governance gates. You will collaborate with global teams (US, Turkey) to ship features end-to-end, maintain data residency and audit trails, and align product strategy with FDA guidance and privacy

Qualifications

6+ years of product management in regulated health software.
Owned PRD, acceptance criteria, and shipped through release gates with validation.
Integration literacy: HL7 FHIR, CDISC ODM-XML, CDASH, EDC and ePRO APIs.
Knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and privacy rules (HIPAA, GDPR, APPI).
AI/ML product experience under a locked-model regime.
Distributed engineering teams; professional English proficiency.

Responsibilities

Own the PRD as a living document with traceability to requirements.
Groom backlog with the team and write engineer-friendly stories.
Translate sponsor/site requests into executable requirements across modules.
Incorporate contract, billing, and data-residency requirements into the product.
Manage the close-out worklist with owners, deadlines, escalation, and audit trail.
Drive roadmap gates: protocol import, EMR/EDC connectors, Japan localization, security/privacy attestations.
Own validation/integrations from a product perspective with regulatory alignment.
Define connector requirements for major EDC and data platforms.