Product Lead, AI-Powered Clinical Trials Platform

Massive Bio, Inc.; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Massive Bio, Inc. is recruiting a Product Lead for the SentinelAgent Platform to transform its oncology action layer. You will own the PRD, write and groom user stories, and drive across time zones with the Turkey-based engineering team, QA, design, and data/ML specialists.

The role emphasizes regulatory compliance and sponsor-facing documentation. You will define connector requirements for key EDC/EMR platforms, maintain a validation package, and ensure audit trails and data residency controls

Qualifications

• 6+ years of product management in regulated health software (eClinical, clinical AI, and EHR integration).
• Owned PRD, wrote acceptance criteria, shipped through release gates with validation backing.
• Integration literacy with HL7 FHIR, CDISC ODM-XML and CDASH; able to read API specs and data-mapping docs.
• Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and privacy rules.
• Professional English; sponsor-facing documentation in English.

Responsibilities

• Own the PRD as a living document with personas and acceptance criteria.
• Groom backlog, write engineer-friendly stories, demo every two weeks, manage release checklists.
• Scope platform modules and translate sponsor/site requests into buildable requirements.
• Define and verify connector requirements (Medidata Rave, Oracle Clinical One, Veeva Vault EDC, SMART on FHIR).
• Drive validation and regulatory alignment with QA, audit trails, and compliance gating.

Skills

Product management

PRD ownership

API integration literacy

Regulatory knowledge

English proficiency

Distributed team leadership

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

EDC APIs

Job description

Massive Bio, Inc. is recruiting a Product Lead for the SentinelAgent Platform to transform its oncology action layer. You will own the PRD, write and groom user stories, and drive across time zones with the Turkey-based engineering team, QA, design, and data/ML specialists.

The role emphasizes regulatory compliance and sponsor-facing documentation. You will define connector requirements for key EDC/EMR platforms, maintain a validation package, and ensure audit trails and data residency controls