Director, Clinical Data Management, Strategy and Operations Lead - Hybrid
Core
Define and lead enterprise Business System Validation strategy, governance, and operations to ensure compliance, quality, and operational excellence across platforms and programs.
Role type
Director, Clinical Data Management, Strategy and Operations Lead
Builds
Enterprise validation capabilities, operating models, standards, and future-state strategies for business systems and platforms
Domain
Healthcare/Pharma (GxP) + Enterprise IT Operations + Validation Engineering
Deliverable
production ML models | dashboards & analysis | infrastructure
Required skills
Enterprise validation strategy, risk-based validation governance, GxP compliance (21 CFR Part 11), program and project governance, enterprise risk management, automation and AI testing guard rails, organizational strategy execution, capacity planning, stakeholder influence
Preferred skills
Digital transformation leadership, AI-enabled validation capabilities, global team leadership, transformation initiatives, vendor engagement
Technologies
GxP frameworks, 21 CFR Part 11, automated testing pipelines, ML model validation tools
Responsibilities
Define enterprise validation strategy and governance mechanisms; oversee validation execution quality and drive continuous improvement; govern validation frameworks and documentation for inspection readiness; lead operational excellence and transformation initiatives; manage portfolio demand, capacity, and resource allocation; establish KPIs and dashboards for performance visibility; serve as strategic partner and Chief of Staff to leadership
Seniority
Director, strategic leadership & operational oversight