Product Lead, Regulated Clinical Trial AI Platform

Massive Bio, Inc.; Kadıköy; On-site; TRY 6,003,000 - 9,005,000; Full time

Job summary

Massive Bio is seeking a Product Lead for the SentinelAgent platform. You will own the PRD, groom the backlog with the Turkey-based engineering team, and drive requirements engineering to deliver a validated, multi-sponsor platform with strict guardrails.

You will manage regulatory alignment (FDA/GxP, 21 CFR Part 11) and collaborate with QA, design, data/ML, and sponsor teams. The role is based in Turkey with global partnerships and shadow-mode pilots in place.

Qualifications

• Must have 6+ years of product management in regulated health software, in eClinical (EDC, CTMS, eSource, eCOA), clinical AI or EHR integration, with releases shipped into GxP / 21 CFR Part 11 validated environments.
• Owned a PRD, written acceptance criteria engineers built against, and shipped through release gates with a validation package behind you.
• Integration literacy: HL7 FHIR, CDISC ODM-XML and CDASH, EDC and ePRO APIs. You can read an API spec and a data-mapping document and find the gap.
• Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11 and the EMA guideline on computerised systems and electronic data in clinical trials, GAMP 5, and privacy and cross-border transfer rules (HIPAA, GDPR, APPI) alongside sponsor data-residency commitments.
• AI/ML product experience under a locked-model regime: you have run a precision/recall or concordance evaluation and defended it to a reviewer.
• You have run product with a distributed engineering team across time zones. Professional working proficiency in English; all sponsor-facing documentation is in English.

Responsibilities

• Own the PRD as a living document. Personas, MoSCoW-prioritized user stories with Given/When/Then acceptance criteria, functional and non-functional requirements, and full traceability: every threshold in the product traces to a requirement ID.
• Run the build with the team in Turkey. Groom the backlog in their working day, write stories an engineer can build without a meeting, demo every two weeks, and keep a release checklist nobody skips.
• Scope across the platform's modules (protocol ingestion, EMR monitoring, the EDC bridge, the ePRO connector, the closure intelligence dashboard, the retention engine, the audit ledger and the orchestrator), turning sponsor and site asks into requirements engineering can build against, and saying no where a guardrail forbids it.
• Build in the contract and billing requirements, not only the clinical ones. Logging of AI processes, prompts and outputs; in-region data residency; billing-state tracking as per SOWs.
• Make the close-out worklist the product. Required follow-up, data and queries, safety reconciliation, product accountability and essential records; assigned owners and deadlines; escalation; review; and audit trail.
• Drive the roadmap through its gates: protocol import, additional EMR and EDC connectors, ePRO and retention workflows, Japan localization, and the security and privacy attestations each gate requires.
• Own the product side of validation and integrations. User requirements, risk assessment and traceability to test under GAMP 5 risk-based validation, aligned to FDA guidance; define connector requirements and acceptance criteria for major platforms; engineering owns certification and listing.

Skills

PRD ownership

Backlog grooming

Requirements engineering

Regulatory/compliance

Cross-functional leadership

Tools

HL7 FHIR

CDISC ODM-XML

CDASH

EDC/ePRO APIs

Job description

Massive Bio is seeking a Product Lead for the SentinelAgent platform. You will own the PRD, groom the backlog with the Turkey-based engineering team, and drive requirements engineering to deliver a validated, multi-sponsor platform with strict guardrails.

You will manage regulatory alignment (FDA/GxP, 21 CFR Part 11) and collaborate with QA, design, data/ML, and sponsor teams. The role is based in Turkey with global partnerships and shadow-mode pilots in place.