Director, Clinical Quality - Program and Process Quality

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Praxis is hiring a Clinical Quality leader who sees quality as a catalyst—not a checkpoint. In this role, you’ll help define and drive a strong GCP quality culture across all clinical programs, balancing rigor with speed and foresight. You’ll oversee clinical quality systems and metrics, anticipate and escalate risk before it becomes an issue, and work shoulder-to-shoulder with Clinical Operations, Regulatory, Safety, and other partners to keep our trials inspection-ready and continuously improving.

At the same time, you’ll support and develop Clinical Quality team members embedded in programs, guiding inspection readiness, deviations, investigations, audits, and CAPAs—while helping shape an integrated, proactive clinical quality strategy that scales with our pipeline.

Primary Responsibilities

Clinical Quality (GCP, GPvP, GCLP) Compliance Oversight

• Develop and report key quality metrics across all clinical programs and trials
• Assess current-state quality across programs, processes, and trials
• Identify trends, risks, and lead process and system improvements
• Ensure compliance with GCP, ICH-GCP, FDA, EMA, PMDA, and applicable regulations