Director, Clinical Data & AI

Life Unlimited. At Smith+Neb 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? Global Clinical Data & AI Strategy Define and execute the global strategy for Clinical Data & AI aligned to enterprise evidence-generation and AI transformation goals Establish a unified operating model integrating: Clinical systems (EDC, eCOA, registries) Clinical Data Lake & central data model Data management and data engineering AI/ML and advanced analytics Serve as the enterprise authority on clinical data architecture and AI enablement for clinical & medical affairs across all BUs and geographies Partner with Clinical Study Management, Clinical Strategy, Regulatory, Medical Affairs, Statistics, and IT to define data-driven evidence strategies Clinical Data Architecture & Platforms Own the design, governance, and evolution of: Clinical Data Lake (CDL) and standardized data models Clinical systems ecosystem (EDC, eCOA, registry ingestion, integrations) Data pipelines, transformation, and interoperability frameworks Ensure scalable, compliant, and extensible architecture supporting: Cross-study analytics Real-world data integration Device + clinical data linkage Drive standardization (e.g., CDISC-based models) and elimination of data silos AI, Data Science & Advanced Analytics Lead development and deployment of AI/ML capabilities across the clinical lifecycle, including: Data quality automation and monitoring AI-assisted clinical study reporting and analytics Cross-study insights and meta-analyses Drive integration of AI into core workflows, not point solutions Establish best practices for: Model development, validation, monitoring Responsible AI (traceability, reproducibility, regulatory alignment) Oversee collaboration between data science, statistics, and programming teams Synthetic Data, Simulation & Virtual Twins Own strategy and execution for: Synthetic clinical data generation Simulation frameworks for study design and operational planning Virtual twin development for patient- and study-level modeling Ensure alignment with regulatory expectations for transparency and scientific validity Integrate synthetic and simulated data into: Study design optimization Evidence generation (e.g., hybrid designs, external controls) Clinical Data Management & Quality Oversee global clinical data management function, ensuring: High-quality, consistent, and inspection-ready data Efficient study startup (eCRF design, database builds) and closeout Risk-based monitoring and analytics-driven data review Embed AI, machine learning modeling, and automation into CDM workflows to improve efficiency and quality Ensure alignment with regulatory and compliance standards (FDA, EU MDR, GDPR, HIPAA) Statistical & Clinical Programming Integration Own alignment and integration of: Statistical programming (TFLs, ADaM outputs) Clinical programming (data pipelines, transformations) Ensure seamless data flow from raw data → analysis-ready datasets → reporting Drive standardization, automation, and reuse across studies and programs Leverage AI solutions to accelerate programming across Global Clinical and Medical Affairs Operational Excellence & Delivery Model Own intake, prioritization, and delivery across: Data platform initiatives AI/ML programs Study-level data operations Implement scalable delivery models for standardized multi-source clinical outcomes datasets from the Clinical Data Lake to key business stakeholder teams Optimize resourcing across: High-throughput standardized work High-complexity AI/data science initiatives Regulatory & Data Governance Leadership Ensure all clinical data and AI activities are: Compliant with global regulatory requirements Traceable, auditable, and reproducible Establish strong governance across: Data standards and lineage AI model lifecycle Data privacy and security Support regulatory submissions with robust, defensible data strategies Key Interfaces Global Clinical Research Operations leadership Clinical / Medical Affairs / Regulatory Affairs Statistics, Data Science, and AI teams IT / Digital / Enterprise Data organizations External partners, CROs, AI vendors, and regulators Education BA required, PhD (preferred) or Master’s in Data Science, Biostatistics, Computer Science, or related field What will you need to be successful? Minimum of 10 years experience across clinical data, AI/ML, and data platforms in medtech/pharma/biotech Proven leadership of multi-domain teams (data management, engineering, data science, AI, programming) Demonstrated ownership of enterprise data architecture (e.g., data lake/platform) – Databricks preferred Strong track record supporting regulatory submissions and clinical evidence generation Enterprise mindset – integrates data, AI, and operations into a unified capability Technical depth + breadth – credible across data engineering, CDM, AI, and analytics Regulatory credibility – understands how data and AI decisions impact submissions Execution rigor – delivers scalable, high-quality platforms and outputs Transformational leadership – embeds AI into workflows, not as isolated innovation Pragmatic innovation – advances capabilities while maintaining compliance and reliability You 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 on 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+Neb 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. #J-18808-Ljbffr