Product Lead – Clinical Trial AI Platform (eClinical)

Massive Bio•New York, VT

About The Position

Massive Bio is hiring a Product Lead for its SentinelAgent™ clinical-trial AI platform. The role will take the platform from early, shadow-mode pilots to a validated, multi-sponsor product, while maintaining clinical, regulatory, privacy, and data-governance guardrails. The position reports to the Chief Medical AI Officer, with a dotted line to the CEO for commercial priorities. There are no direct reports initially. The product and engineering team is based in Turkey, and the Product Lead will work closely with its engineering lead and the engineering, QA, design, and data/ML teams. US-based candidates should plan to start by 7 a.m. Eastern to overlap with Turkey’s working day. The Product Lead owns the product requirements document, backlog, user stories, acceptance criteria, sprint demonstrations, and release checklist. The role coordinates product work across SentinelAgent’s modules and roadmap, translating sponsor and site needs into buildable requirements while enforcing rules such as clinician approval before sponsor-database writes, shadow-first pilots, append-only audit logging, regional data residency, and study-specific model freezes. The role also incorporates contract and billing requirements, develops the close-out worklist experience, and instruments product outcomes. The position owns product-side validation and integration requirements, including user requirements, risk assessment, traceability, and connector acceptance criteria. An independent QA owner approves the validation plan, protocols, and release; engineering owns connector certification and listing, Business Development owns vendor relationships, and the Chief Medical AI Officer makes go/no-go decisions. The Product Lead also works with Regulatory on regulatory-strategy materials, inspection-ready model-performance documentation, and sponsor and partner AI-governance questionnaires. The stated 12-month objectives are to complete the validation package, certify two additional EDC connectors, and move sponsors from shadow mode to live operation. SentinelAgent is a protocol-aware monitoring agent that tracks missing records, overdue follow-up, and unresolved queries; prepares EDC entries for authorized site clinicians to review and confirm under their own logins; and surfaces close-out work for sponsor and site teams. Sponsor and site teams—not Massive Bio—authorize closure.

Requirements

At least 6 years of product-management experience in regulated health software, in eClinical (EDC, CTMS, eSource, or eCOA), clinical AI, or EHR integration.
Experience shipping releases into GxP or 21 CFR Part 11 validated environments.
Experience owning a PRD, writing acceptance criteria engineers can build against, and shipping through release gates with a validation package.
Integration literacy in HL7 FHIR, CDISC ODM-XML and CDASH, and EDC and ePRO APIs; ability to review API specifications and data-mapping documents and identify gaps.
Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11, the EMA guideline on computerised systems and electronic data in clinical trials, and GAMP 5.
Working knowledge of privacy and cross-border transfer rules, including HIPAA, GDPR, and APPI, alongside sponsor data-residency commitments.
AI/ML product experience under a locked-model regime, including running a precision/recall or concordance evaluation and defending it to a reviewer.
Experience running product with a distributed engineering team across time zones.
Professional working proficiency in English; sponsor-facing documentation is in English.

Nice To Haves

Oncology trial data experience, including RECIST, Schedule of Assessments, and long-term and survival follow-up.
Japan experience, including SS-MIX2 hospital systems, PMDA engagement, or APPI.
SOC 2 or HITRUST program experience.
Experience with immutable or hash-chained audit logging.
Experience with LLM-based clinical extraction and its evaluation.
Experience as the first product hire on a product line.

Responsibilities

Own and maintain the product requirements document, including personas, MoSCoW-prioritized user stories, Given/When/Then acceptance criteria, functional and non-functional requirements, and requirement traceability for thresholds.
Groom the backlog with the Turkey-based team, write implementation-ready stories, run sprint demos every two weeks, participate in engineering reviews, and maintain a release checklist.
Scope work across protocol ingestion, EMR monitoring, the EDC bridge, the ePRO connector, the closure intelligence dashboard, the retention engine, the audit ledger, and the orchestrator; translate sponsor and site requests into engineering requirements and enforce product guardrails.
Incorporate contract and billing requirements, including logging AI processes, prompts, and outputs; preventing sponsor confidential information from being used to train or improve models; regional data residency for the US, EU, and Japan; and billing-state tracking aligned with statements of work.
Make the close-out worklist a core product capability, covering required follow-up, data and queries, safety reconciliation, product accountability, essential records, named owners and deadlines, configured escalation, reviewer verification, and audit trails.
Drive the roadmap through protocol import, additional EMR and EDC connectors, ePRO and retention workflows, Japan localization, and required security and privacy attestations.
Own product-side validation and integrations, including user requirements, requirement-level risk assessment, and traceability to testing under GAMP 5 (second edition), aligned with FDA’s 2024 guidance and 21 CFR Part 11 controls.
Define connector requirements and acceptance criteria for Medidata Rave, Oracle Clinical One, Veeva Vault EDC, ePRO platforms, Patient Connect on Reticulum Nexus, SMART on FHIR, Epic Vendor Services, and Oracle Health developer-program tracks.
Work with Regulatory on regulatory-strategy materials supporting clinician-in-the-loop decision-support positioning, inspection-ready model-performance documentation, and responses to sponsor and partner AI-governance questionnaires.
Instrument and report the product measures promised in the PRD, including clinician correction rate, coordinator time reduction, ePRO completion, closure acceleration, and concordance with monitor-verified source.
Coordinate with the engineering team across time zones and work with QA, design, data/ML, Regulatory, Business Development, and clinical and sponsor stakeholders.