Product Lead: AI Platform for Regulated Clinical Trials

Massive Bio, Inc.; Pennsylvania; On-site; USD 180,000 - 240,000; Full time

Job summary

Massive Bio is seeking a Product Lead to take SentinelAgent to a validated, multi‑sponsor platform. You’ll own PRDs, write user stories with Given/When/Then criteria, and guide cross‑functional teams across time zones, ensuring governance gates and regulatory compliance.

You’ll work with engineers, QA, design and data/ML, aligning sponsor requirements with clinical workflow, data residency rules, and secure, auditable processes to deliver safe, scalable clinical trial support.

Qualifications

• 6+ years of product management in regulated health software.
• Owned PRD and release gates with validation behind you.
• Integration literacy with health data standards.

Responsibilities

• Own the PRD as a living document with traceability.
• Groom backlog, write stories, demo every two weeks.
• Define connector requirements and acceptance criteria for integrations.
• Drive regulatory-facing product work and documentation.

Skills

PRD ownership

Acceptance criteria

API integration

HL7 FHIR

Regulatory knowledge

Distributed teams

English proficiency

Tools

CDISC ODM-XML

CDASH

GAMP 5

Job description

Massive Bio is seeking a Product Lead to take SentinelAgent to a validated, multi‑sponsor platform. You’ll own PRDs, write user stories with Given/When/Then criteria, and guide cross‑functional teams across time zones, ensuring governance gates and regulatory compliance.

You’ll work with engineers, QA, design and data/ML, aligning sponsor requirements with clinical workflow, data residency rules, and secure, auditable processes to deliver safe, scalable clinical trial support.