Teams at Maplight Therapeutics

Lead and standardize Clinical Program Management across the clinical development portfolio. Oversee program planning, execution, governance, risk mitigation, cross-functional alignment, and resource management. Develop the PM team, implement best practices and enterprise tools, and support decision-making to ensure consistent, high-quality execution from preclinical into clinical stages.

Lead and oversee statistical programming for clinical development and regulatory submissions. Manage development/validation of SAS programs to produce SDTM/ADaM datasets and TLFs, ensure CDISC and regulatory compliance, partner with biostatistics, data management, clinical and regulatory teams, manage CRO/vendor relationships, and implement tools/process improvements. Perform hands-on SAS programming and support programming deliverables for submissions and study reports.

Lead and manage a team of CRAs while maintaining site management and monitoring for assigned studies. Oversee monitoring quality, develop monitoring plans and tools, perform on-site and centralized monitoring, ensure GCP/ALCOA+ compliance, support inspections, collaborate cross-functionally, and drive process improvements to meet study milestones and risk mitigation goals.