AI Governance and Operations Lead
hace 2 días
Summit
Job DescriptionRole Summary In this role, you will lead enterprise and commercial governance of Generative AI in a highly regulated biopharma environment (US + EU4 + UK). You will sit at the intersection of Security, Legal, Compliance, Internal Communications, and Commercial (Marketing, Omnichannel/CRM, Insights, Market Access) to ensure GenAI solutions are secure, compliant, auditable, and adopted at scale. Assignment Type: 12-month contract (possibility to extend beyond) Key Partners CISO/Information Security · Legal (incl. IP/Contracts) · Privacy/DPO · Compliance/QA/RA · Internal Communications/Training · IT/CAB · Commercial Operations · Marketing · Omnichannel/CRM · Market Access · HEOR/Insights · Medical (MLR/PRC) · Regional Commercial Leads. Core Responsibilities 1. Enterprise AI Governance • Policy Framework: Own the enterprise AI policy framework and control library; coordinate global rollouts with Security, Legal/Privacy, Compliance, and Internal Comms., • Security Baselines: Define and enforce security baselines for GenAI platforms (access governance, secure SDLC, data protection, logging, incident runbooks, red‑teaming/pen‑testing)., • Legal & Contractual: Manage risk classification (incl. EU AI Act), IP and data licensing, DPAs/DTIAs, export controls, and records retention., • Regulatory Alignment: Align AI controls to NIST AI RMF, ISO standards, GDPR/UK GDPR, US privacy regimes, and internal GxP policies., • Training & Comms: Lead internal communication and training for AI policies via enablement kits, role‑based SOPs, and micro‑learning.2. Commercial AI Governance, • Promotional (MLR/PRC): Define guardrails for use (label/PI alignment, fair balance, claims substantiation) and embed checkpoints into AI workflows., • Non‑Promotional / Medical / Insights: Set review pathways for medical information and scientific summaries with SME validation and reproducibility standards., • Omnichannel/CRM: Govern GenAI-assisted segmentation and targeting to ensure explainability and compliance with anti-kickback/sampling rules., • Market Access & HEOR: Govern GenAI use in pricing and access evidence; ensure approved data sources and transparent methods., • Data & Safety: Map and control personal/sensitive data (HCP, patient, employee); establish pharmacovigilance and safety escalation pathways., • Vendor Management: Qualify vendors against security/privacy criteria and maintain a live model registry and use-case inventory.3. AI Operations for Commercial Scale (AIOps/MLOps), • Build and operate production pipelines for GenAI models/agents (CI/CD, gated releases)., • Define and monitor SLOs for accuracy, latency, reliability, and safety tied to commercial KPIs., • Implement observability and safety tooling (evaluation harnesses, red‑team testing) and multi‑agent orchestration.4. Regional Regulatory & Privacy Alignment, • US: Ensure MLR/PRC promotional compliance and 21 CFR Part 11 requirements., • EU4 (DE/FR/IT/ES): Operationalize GDPR and EU AI Act risk controls and data residency., • UK: Maintain UK GDPR-aligned controls and manage works council engagement where relevant. 2026 Outcomes You Will Own • Global Governance: Enterprise AI governance live and operating across US, EU4, and UK., • Security Posture: Vulnerabilities remediated within SLA and red-team findings closed via CAPA., • Audit Readiness: Achieve zero critical audit findings with current validation packages across the portfolio., • Production Scale: 20–30 commercial/market access GenAI solutions in production with green SLOs., • Efficiency: Improved MLR/PRC time-to-approve for GenAI-enabled submissions. Minimum Qualifications • 8+ years in ML/AI governance, MLOps/AIOps, or model risk in regulated environments., • Demonstrated Responsible AI implementation (NIST AI RMF, EU AI Act, and/or ISO)., • Direct Commercial Pharma experience (US/EU4/UK) covering MLR/PRC and Omnichannel ops., • Experience operationalizing multi‑agent GenAI and RAG for commercial workflows., • Tooling Fluency: Major cloud platforms (Azure/AWS/Databricks), MLflow, and policy frameworks., • Proven ability to orchestrate cross-regional sign-offs with C-Suite and regional leadership. Key Operating Cadences & Artifacts • Cadences: Governance Council, Risk Review Board, Model CAB, and Production Health Reviews., • Artifacts: Policy Library, Model Cards/Lineage, DPIA/DTIA Assessments, and MLR/PRC Evidence Packs. Compensation & Search Details • Hourly Pay Range: $90.00 – $110.00 per hour (commensurate with experience) About the Search This search is being managed by Summit Strategic Search on behalf of our client. While you will be engaged through our firm, the end client retains final authority over selection. All offers are contingent upon client approval and successful onboarding. Equal Opportunity Commitment We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, disability status, or any other characteristic protected by law. Accommodations & Support We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at . We maintain a zero-tolerance policy for harassment and provide all contractors with dedicated reporting channels to ensure a safe, professional work environment. Onboarding Requirements Due to the regulated nature of our clients industry and the requirement for on-site presence in Union County, NJ, all candidates must successfully complete the end clients onboarding protocols. This typically includes: • Comprehensive background check., • Drug screening., • Adherence to site-specific security and health policies.