Product Lead, AI-Powered Clinical Trials Platform

Massive Bio, Inc.; United States; Hybrid; USD 140,000 - 210,000; Full time

Job summary

Massive Bio, Inc. is seeking a Product Lead for SentinelAgent Platform to drive a regulated, clinician-in-the-loop product.

You will own the PRD, align with a distributed team across Turkey and the US, and shepherd releases through strict gate processes with QA, validation, and sponsor governance. You will coordinate cross-functional teams including engineering, data/ML, regulatory, and commercial to ensure compliant, scalable integrations and real‑time decision support for clinical trials.

Qualifications

• 6+ years in product management for regulated health software.
• Owned a PRD and shipped releases through gated processes.
• Experience with HL7 FHIR, EDC/CTMS integrations.

Responsibilities

• Own the PRD as a living document with acceptance criteria and traceability.
• Groom the backlog, write user stories, run sprint demos, and manage release checklists.
• Coordinate with global engineering teams, ensure regulatory alignment and audit readiness.
• Define connector requirements and acceptance criteria for EDC/EMR integrations and vendor platforms.
• Drive the roadmap through gates and maintain documentation for FDA-compliant validation.

Skills

Product management

Regulated health software

PRD ownership

HL7 FHIR

21 CFR Part 11

English proficiency

Tools

APIs

FDA guidelines

Job description

Massive Bio, Inc. is seeking a Product Lead for SentinelAgent Platform to drive a regulated, clinician-in-the-loop product.

You will own the PRD, align with a distributed team across Turkey and the US, and shepherd releases through strict gate processes with QA, validation, and sponsor governance. You will coordinate cross-functional teams including engineering, data/ML, regulatory, and commercial to ensure compliant, scalable integrations and real‑time decision support for clinical trials.