Product Lead – Clinical Trial AI Platform (eClinical)

Massive Bio•Boca Raton, FL

About The Position

Massive Bio is seeking a Product Lead for its SentinelAgent™ clinical trial AI platform. The role will take the platform from early, shadow-mode sponsor pilots to a validated, multi-sponsor product while maintaining strict clinical, regulatory, privacy, and data-integrity 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 in Turkey, and the role partners closely with its engineering lead and with 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 PRD as a living document, backlog, user stories, acceptance criteria, sprint demos, release checklists, and product requirements across the platform’s modules. The role translates sponsor and site needs into buildable requirements and owns product-side validation, integration requirements, regulatory-facing product materials, and instrumentation of product outcomes. Releases are gated by product acceptance, QA validation, site user acceptance testing, and a go/no-go decision by the Chief Medical AI Officer. The 12-month goals are to complete the validation package, certify two additional EDC connectors, and move sponsors into live operation beyond shadow mode. SentinelAgent™ is a protocol-aware monitoring agent on the Reticulum Nexus platform. It tracks missing records, overdue follow-up, and unresolved queries; prepares sponsor EDC entries for an authorized site clinician to review and confirm; and surfaces open items delaying close-out. It uses an append-only audit trail, and sponsor and site teams—not Massive Bio—authorize closure. The product is contracted, priced, and delivered separately from Massive Bio’s trial-matching and patient-navigation services.

Requirements

At least 6 years of product management experience in regulated health software, eClinical (EDC, CTMS, eSource, eCOA), clinical AI, or EHR integration.
Experience shipping releases into GxP / 21 CFR Part 11 validated environments.
Experience owning a PRD, writing acceptance criteria used by engineers, 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 conducting 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 PRD, including personas, MoSCoW-prioritized user stories, Given/When/Then acceptance criteria, functional and non-functional requirements, and traceability from every product threshold to a requirement ID.
Run product delivery with the Turkey-based team: groom the backlog, write implementation-ready stories, lead sprint demos every two weeks, participate in engineering reviews, and maintain a release checklist.
Scope requirements across protocol ingestion, EMR monitoring, the EDC bridge, ePRO connector, closure intelligence dashboard, retention engine, audit ledger, and orchestrator; translate sponsor and site requests into requirements and enforce product guardrails.
Ensure product requirements preserve clinician approval before data enters a sponsor database, prohibit autonomous operation, maintain append-only hash-chained audit logging, keep patient data within its home region, freeze model versions per study, and require pilots to run in shadow mode first.
Build contract and billing requirements into the product, including AI process, prompt, and output logging; prohibition on using sponsor confidential information to train or improve models; US, EU, and Japan data residency; and billing-state tracking aligned with each statement of work.
Make the close-out worklist the product, covering required follow-up, data and queries, safety reconciliation, product accountability, essential records, named owners and deadlines, configured escalation, reviewer verification, and audit trails for completed items.
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 requirement-to-test traceability under GAMP 5 (second edition), aligned with FDA’s 2024 guidance on electronic systems, records, and signatures 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, and Epic Vendor Services and Oracle Health developer-program tracks.
Work with Regulatory on regulatory-strategy materials supporting clinician-in-the-loop decision-support positioning; keep model-performance documentation inspection-ready; and respond to sponsor and partner AI-governance questionnaires.
Instrument and deliver product readouts for clinician correction rate, coordinator time reduction, ePRO completion, close-out acceleration, and concordance with monitor-verified source.
Coordinate with QA, whose independent owner approves the validation plan, protocols, and release; with the Director of Business Development & Client Delivery, who facilitates site user acceptance testing; and with the Chief Medical AI Officer, who makes go/no-go decisions.