Product Lead, AI-Driven Clinical Trials Platform
Massive Bio, Inc.
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Job summary
Massive Bio is hiring a Product Lead for the SentinelAgent Platform to advance a regulated, multi-sponsor solution for clinical trial orchestration. You will own PRD, write clear user stories, and guide a distributed team across Turkey and the US, ensuring guardrails on data residency, privacy, and auditability.
You will drive cross-functional collaboration with regulatory, QA, engineering, and business development to deliver validated capabilities in shadow mode and live deployments, with a
Qualifications
- 6+ years of product management in regulated health software.
- Owned PRD, written acceptance criteria, and shipped through release gates with validation packages.
- Integration literacy: HL7 FHIR, CDISC ODM-XML and CDASH, EDC and ePRO APIs.
- Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and GDPR/HIPAA privacy rules.
- Experience with distributed engineering teams and professional English proficiency.
Responsibilities
- Own the PRD as a living document with acceptance criteria and traceability.
- Run the build with the team in Turkey, groom backlog, and write actionable stories.
- Scope across platform modules and enforce data residency, privacy, and auditability guardrails.
- Define contract and billing requirements, and maintain audit trails.
- Make the close-out worklist and escalation processes tangible for sponsors and sites.
- Drive roadmap gates: protocol imports, additional connectors, localization, and attestations.
- Own product side of validation and regulatory-compliant releases with QA and documentation.
Skills
Tools
Job description
Massive Bio is hiring a Product Lead for the SentinelAgent Platform to advance a regulated, multi-sponsor solution for clinical trial orchestration. You will own PRD, write clear user stories, and guide a distributed team across Turkey and the US, ensuring guardrails on data residency, privacy, and auditability.
You will drive cross-functional collaboration with regulatory, QA, engineering, and business development to deliver validated capabilities in shadow mode and live deployments, with a
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