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 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.

Lead pharmacovigilance safety surveillance for assigned products, including medical review of ICSRs, signal detection and assessment, aggregate report (DSUR/PBRER) preparation, risk management planning, regulatory safety writing, SOP updates, and PV audit/inspection participation. Collaborate with program leads, PV operations, CROs, and clinical teams to ensure compliant, proactive safety monitoring across the product lifecycle.