Product Manager (Clinical AI)

Location: Hybrid in Kadıköy, Istanbul, Turkey

Company

hirify.global is an AI-powered precision medicine platform connecting cancer patients with clinical trials and supporting pharmaceutical companies, CROs, and healthcare systems. SentinelAgent™ is a protocol-aware monitoring agent for clinical-trial follow-up, data, safety, records, and close-out workflows.

What you will do

• Own the living PRD, personas, MoSCoW-prioritized user stories, Given/When/Then acceptance criteria, functional and non-functional requirements, and full requirement traceability.
• Run backlog grooming, write build-ready stories, lead biweekly demos, maintain release checklists, and coordinate with engineering, QA, design, and data/ML in Turkey.
• Scope protocol ingestion, EMR monitoring, EDC and ePRO connectors, closure intelligence, retention workflows, audit logging, and orchestration while enforcing clinician approval, regional data residency, locked-model, append-only audit, and shadow-first safeguards.
• Drive protocol import, connector certification, Japan localization, ePRO and retention workflows, and security and privacy attestation gates.
• Own product-side validation and integrations for Medidata Rave, Oracle Clinical One, Veeva Vault EDC, ePRO platforms, SMART on FHIR, Patient Connect, Epic Vendor Services, and Oracle Health developer programs.
• Support regulatory strategy, AI-governance responses, inspection-ready model documentation, product measurement, and close-out worklists covering follow-up, queries, safety reconciliation, accountability, and essential records.

Requirements

• 6+ years of product management experience in regulated health software, including eClinical, clinical AI, or EHR integration, with releases shipped into GxP or 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.
• Working knowledge of HL7 FHIR, CDISC ODM-XML, CDASH, EDC and ePRO APIs, including the ability to review API specifications and data-mapping documents.
• Working knowledge of ICH E6(R3), 21 CFR Part 11, EU Annex 11, the EMA guideline on computerized systems and electronic data in clinical trials, GAMP 5, HIPAA, GDPR, APPI, privacy, cross-border transfers, and data-residency commitments.
• AI/ML product experience under a locked-model regime, including running and defending precision/recall or concordance evaluations.
• Experience running product with a distributed engineering team across time zones.
• Professional working proficiency in English; all sponsor-facing documentation is in English.
• Validated eClinical product experience and remote-team experience are sufficient to apply even without experience with every listed standard.

Nice to have

• Oncology trial data experience, including RECIST, Schedule of Assessments, and long-term or survival follow-up.
• Japan-related experience with SS-MIX2 hospital systems, PMDA engagement, or APPI.
• SOC 2 or HITRUST program experience and immutable or hash-chained audit logging.
• LLM-based clinical extraction and evaluation experience.
• Turkish for day-to-day collaboration with the engineering team; helpful but not required.
• Experience as the first product hire for a product line.

Culture & Benefits

• Work in a hybrid setup with the product and engineering team in Turkey.
• Collaborate with engineers, QA, design, data/ML, Regulatory, Business Development, site users, and oncology sponsors across the United States, Europe, and Asia.
• Report to the Chief Medical AI Officer with a dotted line to the CEO for commercial priorities; no direct reports initially.
• Operate in a regulated, clinician-in-the-loop environment where releases require product, QA, site-user, and executive gates.