Product Lead — AI Clinical Trials Platform

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

Job summary

Massive Bio, Inc. seeks a Product Lead for the SentinelAgent™ Platform. You will own the PRD, prioritize features, and drive end‑to‑end product delivery with a distributed team, ensuring FDA/21 CFR Part 11 compliant processes and secure data handling.

You will coordinate with engineering, QA, design, and data/ML teams across time zones, steering the platform from pilot to multi‑sponsor deployment while maintaining governance and traceability.

Qualifications

• 6+ years of product management in regulated health software (eClinical, AI or EHR integration).
• Owned PRD, written acceptance criteria, and shipped through release gates with a validation package.
• Integration literacy: HL7 FHIR, CDISC ODM-XML, CDASH and API specs.

Responsibilities

• Own the PRD as a living document with user stories and acceptance criteria.
• Groom backlog, write stories, run sprint demos and manage release checklists.
• Lead cross‑functional work with engineering in Turkey and sponsor sites, ensuring guardrails and regulatory compliance.

Skills

PRD ownership

Acceptance criteria

Regulated health software

HL7 FHIR

21 CFR Part 11

English proficiency

Job description

Massive Bio, Inc. seeks a Product Lead for the SentinelAgent™ Platform. You will own the PRD, prioritize features, and drive end‑to‑end product delivery with a distributed team, ensuring FDA/21 CFR Part 11 compliant processes and secure data handling.

You will coordinate with engineering, QA, design, and data/ML teams across time zones, steering the platform from pilot to multi‑sponsor deployment while maintaining governance and traceability.