Product Lead - AI Platform for Regulated Clinical Trials

Massive Bio, Inc.; Maryland; On-site; USD 140,000 - 190,000; Full time

Job summary

Massive Bio seeks a Product Lead for SentinelAgent™ Platform to drive the roadmap from pilot to a validated multi‑sponsor system. You’ll own the PRD, manage cross‑functional teams in Turkey and the US, and ensure regulatory and data‑residency requirements are met with rigorous audit trails.

You will collaborate with clinical, product, and engineering to deliver secure, compliant solutions, while maintaining sponsor and site efficacy through validated workflows.

Qualifications

• 6+ years of product management in regulated health software.
• Experience owning PRD and guiding releases through gated processes.
• Knowledge of HL7 FHIR, CDISC ODM-XML and ePRO APIs.
• Professional English, with experience coordinating across time zones.

Responsibilities

• Own the PRD as a living document with acceptance criteria and traceability.
• Lead cross-functional build with teams in Turkey and the US.
• Define regulatory and clinical requirements and validation plans.
• Manage contract/billing requirements and audit trails for compliance.

Skills

PRD ownership

Release gates

Regulated health software

English proficiency

Distributed teams

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

ePRO APIs

Job description

Massive Bio seeks a Product Lead for SentinelAgent™ Platform to drive the roadmap from pilot to a validated multi‑sponsor system. You’ll own the PRD, manage cross‑functional teams in Turkey and the US, and ensure regulatory and data‑residency requirements are met with rigorous audit trails.

You will collaborate with clinical, product, and engineering to deliver secure, compliant solutions, while maintaining sponsor and site efficacy through validated workflows.