Director, Data Management Operational Excellence
Core
Enterprise leader designing and advancing the global operating model for Data Management and Clinical Data Standards to ensure scalable, high-quality, inspection-ready data delivery across Moderna's development portfolio.
Role type
Director, Data Management Operational Excellence
Builds
Global Data Management operating model, enterprise governance frameworks, KPI/performance analytics systems, inspection readiness strategies, and vendor oversight models.
Domain
Pharmaceutical/Biotechnology, Clinical Data Management, Regulatory Compliance (GxP)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical data management leadership, operational excellence/transformation, governance framework design, KPI system implementation, vendor oversight strategy, digital innovation/automation, regulatory GxP compliance, inspection readiness, cross-functional stakeholder influence, resource modeling, team leadership and mentoring
Preferred skills
Advanced degree in life/data sciences, experience advancing digital innovation/automation in clinical development
Technologies
GxP regulations (GCP, GCDM, GDocP), FDA regulations, ICH GCP guidelines, global regulatory standards
Responsibilities
Lead strategic design of global Data Management operating model; Establish enterprise-wide governance frameworks and decision-rights models; Define and oversee KPI and performance analytics frameworks; Drive inspection readiness strategy and audit-ready processes; Represent Data Management as SME during regulatory inspections and audits; Oversee vendor governance strategy and performance standards; Partner with Clinical Operations, Biometrics, Quality, and Regulatory functions; Lead enterprise process harmonization and SOP strategy; Champion digital enablement and automation initiatives; Identify and mitigate systemic operational risks; Influence resource modeling and portfolio capacity planning; Build organizational capability and mentor leaders; Establish succession and employee development plans
Seniority
Director, strategic leadership with hands-on oversight