Product Lead, AI-Driven Clinical Trials Platform

Massive Bio, Inc.

South Carolina

Hybrid

USD 150,000 - 210,000

Full time

6 days ago

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Job summary

Massive Bio is seeking a Product Lead for SentinelAgent Platform to take a regulated health software product from pilot to a validated, multi‑sponsor solution. You will work with our Turkey team and sponsor sites, manage the PRD, backlogs, and release gates, and own the roadmap for protocol ingestion, EMR/EDC connectors, and privacy controls.

You will ensure in‑region data residency, compliance with 21 CFR Part 11, and data governance while coordinating with QA, regulatory, and BD teams.

Qualifications

6+ years of product management in regulated health software, in eClinical, clinical AI or EHR integration.
Owned a PRD, acceptance criteria, and release gates with a validation package.
Integration literacy: HL7 FHIR, CDISC ODM-XML and CDASH; can read API specs and data mappings.
Proficiency in English; sponsor-facing documentation is in English.

Responsibilities

Own the PRD as a living document with user stories and acceptance criteria.
Groom the backlog, write stories, run biweekly demos, and manage release checklists.
Scope platform modules and translate sponsor/site asks into actionable requirements.
Ensure regulatory and billing requirements are embedded in the product lifecycle.
Drive roadmap gates for protocol import, connectors, and localization.
Oversee validation and integrations with QA, regulatory, and vendor teams.
Ship readouts and maintain audit trails per compliance standards.