Overview You lead the global Clinical Data & AI function to enable end-to-end evidence generation. You shape strategy, architecture, and operations for clinical data, AI, and synthetic data across BUs and geographies. You drive interoperable data platforms, data governance, and AI-enabled workflows that support regulatory and scientific decision-making. You collaborate with clinical, regulatory, statistics, IT, and medical affairs to deliver scalable, compliant solutions. This role offers the opportunity to advance data-driven medicine at scale and influence regulatory submissions.
Compensation / Benefits- medical, dental, and vision coverage
- 401(k)
- tuition reimbursement
- parential leave
- generous PTO
- paid holidays
Responsibilities- Define and execute global Clinical Data & AI strategy aligned to evidence-generation goals
- Own design, governance, and evolution of CDL, data models, and clinical systems ecosystem
- Lead development and deployment of AI/ML across the clinical lifecycle and ensure responsible AI practices
- Oversee Synthetic Data, Simulation, and Virtual Twin strategies and integration into study design
- Manage global Clinical Data Management with AI/automation to improve quality and efficiency
- Align statistical programming and clinical programming data flows with automated, reusable processes
- Establish scalable delivery models for multi-source datasets and cross-functional delivery
- Ensure global regulatory compliance, data standards, privacy, and governance across data and AI
Key requirements- Minimum 10 years in clinical data, AI/ML, and data platforms within medtech/biotech/pharma
- Proven multi-domain leadership across data management, data engineering, data science, AI, and programming
- Experience with enterprise data architecture (data lake/platform); Databricks preferred
- Track record supporting regulatory submissions and clinical evidence generation
- Strong enterprise mindset to integrate data, AI, and operations into a unified capability
- Regulatory credibility and understanding of data/AI impact on submissions
- Execution-driven with ability to deliver scalable, high-quality platforms
- Transformational leadership to embed AI into workflows and pragmatic innovation
- cross-functional collaboration
- transformational leadership
- pragmatic innovation
- Clinical Data Lake / CDM design and governance
- CDISC-based models and data interoperability
- AI/ML model development, validation, monitoring, and governance
