LB Pharmaceuticals

The Director will establish and lead the internal Statistical Programming function, overseeing infrastructure, team building, and process development. They will serve as the lead programmer for CNS clinical trials and manage regulatory submission activities including BLA and NDA filings.

Establish and manage a risk-based quality strategy and audit program for clinical development and pharmacovigilance activities. Lead inspection readiness for global health authorities and oversee the quality management system, including SOPs and CAPAs.

Lead the planning, execution, and oversight of Phase 1–3 clinical trials, ensuring alignment between clinical strategy and operational delivery. Manage external vendors and CROs while integrating field insights from Medical Science Liaisons into clinical planning.