• Act as the primary business systems partner for Clinical Development, Research, and CMC teams, translating scientific, operational, and analytical needs into compliant, scalable system solutions. • Provide strategic oversight of systems supporting clinical trials, research operations, manufacturing, quality, and clinical data analysis, ensuring data integrity, traceability, and inspection readiness. • Partner with Clinical Operations, Biostatistics, Data Management, Research, Technical Operations, and Quality to define system roadmaps aligned with development milestones. • Lead oversight and governance of SAS environments used for clinical data analysis. • Partner with Biostatistics, Clinical Data Management, and external vendors to support the use of SAS for analysis and reporting. • Own the lifecycle management of regulated and enterprise systems, including selection, implementation, validation, integration, and ongoing optimization. • Ensure effective system integrations and data flows between clinical, analytical, quality, and CMC systems. • Serve as a subject matter expert on system controls, access management, and change management in regulated environments. • Lead GxP compliance for systems supporting GCP, GMP, and GLP activities as applicable. • Partner closely with Quality to support regulatory inspections, audits, and system-related responses. • Develop, maintain, and enforce policies, SOPs, and controls governing validated systems, data integrity, and compliance. • Serve as a trusted liaison between Clinical Development, Biostatistics, Data Management, Research, CMC, Quality, IT, and external vendors. • Provide guidance, training, and best practices to stakeholders on compliant system use. • Influence adoption of standardized, compliant solutions across Development and CMC teams. • Proactively identify system gaps, compliance risks, and opportunities to improve efficiency across Development, analytics, and CMC operations.