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About the Role
You will own the SentinelAgent™ platform, taking it from early pilots to a validated, multi-sponsor platform. You will decide what gets built, in what order, and ensure it can be validated by regulated sponsors. This role reports to the Chief Medical AI Officer, with a dotted line to the CEO for commercial priorities. The product and engineering team is based in Turkey, and you will collaborate closely with them.
Responsibilities
- Own the PRD as a living document, including personas, prioritized user stories with acceptance criteria, and functional/non-functional requirements.
- Run the build process with the engineering team in Turkey, grooming the backlog, writing stories, and demoing bi-weekly.
- Scope across the platform's modules, translating sponsor and site requests into buildable requirements.
- Incorporate contract and billing requirements, including AI process logging and data residency.
- Develop the close-out worklist functionality, including follow-up, data, safety reconciliation, and audit trails.
- Drive the product roadmap through defined gates, including protocol import, EMR/EDC connectors, and localization.
- Own the product side of validation and integrations, including user requirements, risk assessment, and traceability to GAMP 5 standards.
- Define connector requirements and acceptance criteria for various EMR, EDC, and ePRO platforms.
- Manage regulatory-facing product work, including strategy materials and AI governance questionnaires.
- Instrument the product to measure key performance indicators and ship readouts.
Requirements
- 6+ years of product management experience in regulated health software (eClinical, clinical AI, or EHR integration) with GxP/21 CFR Part 11 validated releases.
- Experience owning a PRD, writing acceptance criteria, and shipping through release gates with a validation package.
- Integration literacy including HL7 FHIR, CDISC ODM-XML, CDASH, EDC and ePRO APIs.
- Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11, GAMP 5, and privacy regulations (HIPAA, GDPR, APPI).
- AI/ML product experience under a locked-model regime, including evaluation and defense of performance metrics.
- Experience managing a distributed engineering team across time zones.
- Professional working proficiency in English.
Skills
- Product Management
- Regulated Health Software
- eClinical
- Clinical AI
- EHR Integration
- GxP
- 21 CFR Part 11
- HL7 FHIR
- CDISC ODM-XML
- CDASH
- EDC APIs
- ePRO APIs
- ICH E6(R3)
- EU Annex 11
- GAMP 5
- HIPAA
- GDPR
- APPI
- AI/ML
- Distributed Team Management
Location
- US
- Turkey
Work Type
- Full-time
- Remote
Experience Level
- 6+ years of product management experience
About the Company
- Massive Bio is an AI-powered precision medicine platform transforming how cancer patients discover and access clinical trials.
- Founded in 2015 and headquartered in the US, Massive Bio operates globally, connecting patients to clinical trials worldwide.
- The company partners with pharmaceutical companies, CROs, and healthcare systems to accelerate drug development and expand access to therapies.
- SentinelAgent™ is Massive Bio's protocol-aware monitoring agent on the Reticulum Nexus platform, designed to streamline the process from trial option to patient enrollment and follow-up.
- Massive Bio is headquartered in Boca Raton, Florida, with a product and engineering team in Turkey, serving oncology sponsors in the US, Europe, and Asia.