Jobs at Maplight Therapeutics

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 statistical aspects of clinical projects: design sample size/power, author SAP and statistical protocol sections, oversee CRO statistical deliverables, contribute to CSR and regulatory documents, support publications, and collaborate with cross-functional clinical and regulatory teams.

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 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.