Lead Product Manager — AI Platform for Clinical Trials

Massive Bio, Inc.; New Hampshire; On-site; USD 120,000 - 180,000; Full time

Job summary

Massive Bio, a US-based oncology AI company, seeks a Product Lead for SentinelAgent™ to drive the platform from pilot to multi-sponsor release. You will own the PRD, groom a distributed backlog, and translate sponsor and clinical requirements into engineering-ready specifications.

You will collaborate with Turkey-based engineers, QA, design, and data teams while ensuring regulatory compliance and live-site readiness.

Qualifications

• 6+ years of product management in regulated health software (EDC, CTMS, eSource, eCOA) and validated environments.
• Owned a PRD with acceptance criteria and released through release gates with a validation package.
• Integration literacy: HL7 FHIR, CDISC ODM-XML, and CDASH; able to read API specs and data mappings to identify gaps.
• Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and EMA guidance on clinical trial software; GAMP 5 and privacy rules.
• AI/ML product experience under a locked-model regime with evaluation and defense to reviewers.
• Professional English proficiency; sponsor-facing documentation is in English.

Responsibilities

• Own the PRD as a living document with personas and acceptance criteria.
• Groom the backlog with the Turkey-based team; write executable stories and demo every two weeks.
• Translate sponsor and site requests into requirements across protocol ingestion, EMR/EDC connectors, ePRO, and retention workflows.
• Define connector requirements and acceptance criteria for Medidata Rave, Oracle Clinical One and Veeva Vault EDC, ePRO and SMART on FHIR.
• Lead the validation and regulatory work: risk assessment, CSV planning, and 21 CFR Part 11 compliance.
• Drive the roadmap gates: protocol import, additional connectors, Japan localization, and security attestations.
• Ensure audit trails, data residency, and model governance align with sponsor deployments.

Skills

PRD ownership

Story writing

Backlog grooming

Sprint demos

English proficiency

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

EDC APIs

ePRO APIs

Job description

Massive Bio, a US-based oncology AI company, seeks a Product Lead for SentinelAgent™ to drive the platform from pilot to multi-sponsor release. You will own the PRD, groom a distributed backlog, and translate sponsor and clinical requirements into engineering-ready specifications.

You will collaborate with Turkey-based engineers, QA, design, and data teams while ensuring regulatory compliance and live-site readiness.