Director, Clinical Data & AI

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Director of Clinical Data & AI is the global functional leader responsible for the strategy, architecture, and operational execution of clinical data and AI capabilities supporting end-to-end evidence generation. This role owns the clinical data lifecycle—from data acquisition and management to advanced analytics, AI enablement, and synthetic/simulated data—ensuring all data assets are high-quality, interoperable, and fit-for-purpose for regulatory, scientific, and operational decision-making. The Director serves as the enterprise authority on clinical data platforms and AI-enabled evidence generation, driving integration across clinical systems, data engineering, AI/ML, and statistical/clinical programming. This position has full accountability for the strategy, execution, quality, and evolution of the Clinical Data & AI function globally.What will you be doing?1. Global Clinical Data & AI StrategyDefine and execute the global strategy for Clinical Data & AI aligned to enterprise evidence-generation and AI transformation goalsEstablish a unified operating model integrating:Clinical systems (EDC, eCOA, registries)Clinical Data Lake & central data modelData management and data engineeringAI/ML and advanced analyticsServe as the enterprise authority on clinical data architecture and AI enablement for clinical & medical affairs across all BUs and geographiesPartner with Clinical Study Management, Clinical Strategy, Regulatory, Medical Affairs, Statistics, and IT to define data-driven evidence strategies2. Clinical Data Architecture & PlatformsOwn the design, governance, and evolution of:Clinical Data Lake (CDL) and standardized data modelsClinical systems ecosystem (EDC, eCOA, registry ingestion, integrations)Data pipelines, transformation, and interoperability frameworksEnsure scalable, compliant, and extensible architecture supporting:Cross-study analyticsReal-world data integrationDevice + clinical data linkageDrive standardization (e.g., CDISC-based models) and elimination of data silos3. AI, Data Science & Advanced AnalyticsLead development and deployment of AI/ML capabilities across the clinical lifecycle, including:Data quality automation and monitoringAI-assisted clinical study reporting and analyticsCross-study insights and meta-analysesDrive integration of AI into core workflows, not point solutionsEstablish best practices for:Model development, validation, monitoringResponsible AI (traceability, reproducibility, regulatory alignment)Oversee collaboration between data science, statistics, and programming teams4. Synthetic Data, Simulation & Virtual TwinsOwn strategy and execution for:Synthetic clinical data generationSimulation frameworks for study design and operational planningVirtual twin development for patient- and study-level modelingEnsure alignment with regulatory expectations for transparency and scientific validityIntegrate synthetic and simulated data into:Study design optimizationEvidence generation (e.g., hybrid designs, external controls)5. Clinical Data Management & QualityOversee global clinical data management function, ensuring:High-quality, consistent, and inspection-ready dataEfficient study startup (eCRF design, database builds) and closeoutRisk-based monitoring and analytics-driven data reviewEmbed AI, machine learning modeling, and automation into CDM workflows to improve efficiency and qualityEnsure alignment with regulatory and compliance standards (FDA, EU MDR, GDPR, HIPAA)6. Statistical & Clinical Programming IntegrationOwn alignment and integration of:Statistical programming (TFLs, ADaM outputs)Clinical programming (data pipelines, transformations)Ensure seamless data flow from raw data analysis-ready datasets reportingDrive standardization, automation, and reuse across studies and programsLeverage AI solutions to accelerate programming across Global Clinical and Medical Affairs7. Operational Excellence & Delivery ModelOwn intake, prioritization, and delivery across:Data platform initiativesAI/ML programsStudy-level data operationsImplement scalable delivery models for standardized multi-source clinical outcomes datasets from the Clinical Data Lake to key business stakeholder teamsOptimize resourcing across:High-throughput standardized workHigh-complexity AI/data science initiatives8. Regulatory & Data Governance LeadershipEnsure all clinical data and AI activities are:Compliant with global regulatory requirementsTraceable, auditable, and reproducibleEstablish strong governance across:Data standards and lineageAI model lifecycleData privacy and securitySupport regulatory submissions with robust, defensible data strategiesKey InterfacesGlobal Clinical Research Operations leadershipClinical / Medical Affairs / Regulatory AffairsStatistics, Data Science, and AI teamsIT / Digital / Enterprise Data organizationsExternal partners, CROs, AI vendors, and regulatorsEducationBA required, PhD (preferred) or Master’s in Data Science, Biostatistics, Computer Science, or related fieldWhat will you need to be successful?Minimum of 10 years experience across clinical data, AI/ML, and data platforms in medtech/pharma/biotechProven leadership of multi-domain teams (data management, engineering, data science, AI, programming)Demonstrated ownership of enterprise data architecture (e.g., data lake/platform) – Databricks preferredStrong track record supporting regulatory submissions and clinical evidence generationEnterprise mindset – integrates data, AI, and operations into a unified capabilityTechnical depth + breadth – credible across data engineering, CDM, AI, and analyticsRegulatory credibility – understands how data and AI decisions impact submissionsExecution rigor – delivers scalable, high-quality platforms and outputsTransformational leadership – embeds AI into workflows, not as isolated innovationPragmatic innovation – advances capabilities while maintaining compliance and reliabilityYou Unlimited.The anticipated base compensation range for this position is $165,250-$236,000 USD annually. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, and geographic location. Compensation decisions are dependent upon the facts and circumstances of each position and candidate. In addition to base pay, we offer competitive bonus and benefits, including medical, dental, and vision coverage, 401(k), tuition reimbursement, medical leave programs, parental leave, generous PTO, paid company holidays, 8 hours of volunteer time annually, and a variety of wellness offerings such as EAP.Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement  Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day  Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (For most professional roles)  Training: Hands-On, Team-Customized, Mentorship  Extra Perks: Discounts on fitness clubs, travel and more!  Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.Stay connected by joining our Talent Community.We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.Explore our website and learn more about our mission, our team, and the opportunities we offer. SummaryLocation: Andover, MA; Mansfield, MA; Fort Worth; Pittsburgh, PA; Memphis, TN; Austin, TXType: Full time