Product Lead, SentinelAgent AI Platform

Massive Bio, Inc.; Ohio; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Massive Bio is seeking a Product Lead for SentinelAgent™ to advance a regulated health software platform for oncology trial management. You will own the PRD, define user stories, and guide cross‑functional teams across time zones, ensuring guardrails and compliance.

You'll partner with engineering in Turkey, QA, design, and data/ML to deliver a validated, multi‑sponsor platform, manage risk, and drive the roadmap through gates while maintaining FDA/21 CFR Part 11 standards.

Qualifications

• 6+ years of product management in regulated health software, in eClinical (EDC, CTMS, eSource, eCOA), clinical AI or EHR integration.
• PRD ownership with acceptance criteria and gated releases.
• Integration literacy: HL7 FHIR, CDISC ODM-XML and CDASH, EDC and ePRO APIs. Read API specs and data-mapping documents.
• Knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and EMA guidelines, GAMP 5, privacy and cross-border transfer rules (HIPAA, GDPR, APPI).
• Experience with AI/ML product in a locked-model regime.
• English proficiency; sponsor-facing docs in English.

Responsibilities

• Own PRD as living document with personas and acceptance criteria.
• Groom the backlog with the engineering team in Turkey; write stories and run demos.
• Scope across modules: protocol ingestion, EMR monitoring, EDC bridge, ePRO connectors, and dashboards; enforce guardrails.
• Manage contract and billing requirements, logging, data residency, and audit trails per regulations.
• Drive roadmap through gates and ensure validation and regulatory alignment.
• Own validation and integrations with regulatory documentation and vendor tracks.

Skills

Regulated health PM

PRD ownership

APIs HL7 FHIR

GxP / 21 CFR Part 11

English proficiency

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

EDC APIs

ePRO APIs

Job description

Massive Bio is seeking a Product Lead for SentinelAgent™ to advance a regulated health software platform for oncology trial management. You will own the PRD, define user stories, and guide cross‑functional teams across time zones, ensuring guardrails and compliance.

You'll partner with engineering in Turkey, QA, design, and data/ML to deliver a validated, multi‑sponsor platform, manage risk, and drive the roadmap through gates while maintaining FDA/21 CFR Part 11 standards.