Jobs at Maplight Therapeutics

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.

Support regulatory lead with IND/CTA submissions and agency communications, maintain regulatory documentation and correspondence logs, collaborate with CROs and cross-functional teams, monitor regulatory guidance, and support project goals. Hybrid role with occasional travel for in-person meetings.

Manage and operate the company contract management system; draft, review, negotiate, and administer clinical, supply, commercial, and other agreements; develop policies, templates, and workflows; train business users; manage outside counsel and vendors; and support legal, procurement, and finance systems integration while aligning contracting with company objectives.

Lead market research, forecasting, and competitive intelligence to inform commercial launch planning and strategy for lead asset and pipeline. Build forecasts, KPIs, dashboards, synthesize syndicated and primary data, and provide cross-functional commercial insights to support launch, market access, and executive decision-making in a pre-commercial biotech environment.

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 clinical data management from study start-up through database lock. Develop data and validation plans, manage Medidata Rave setup, perform data cleaning and reconciliation, generate quality metrics and listings, support regulatory submissions, and collaborate with clinical, biostatistics, and regulatory teams to ensure data integrity and compliance.

Support clinical operations across all trial phases: manage TMF and study documents, coordinate systems access, liaise with sites/CROs/vendors, prepare meeting materials and minutes, maintain trackers, assist with clinical trial insurance and data review, and ensure compliance with SOPs and ICH-GCP.

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.

Support clinical business operations across multiple studies including vendor selection, RFP management, contract and budget negotiation, Coupa budget entry, performance metrics, and cross-functional coordination to streamline processes and track contract status.