LB Pharmaceuticals

The Director oversees the Major Depressive Disorder clinical program to ensure trials are completed on time, within budget, and in compliance with regulatory guidelines. Key duties include managing CROs, mitigating study risks, and ensuring inspection readiness across clinical sites.

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.