Director, Clinical Quality - Program and Process Quality

Role Summary

Location: remote with travel as needed. Praxis is seeking a Clinical Quality leader who treats quality as a catalyst across all clinical programs, balancing rigor with speed and foresight. The role involves overseeing clinical quality systems and metrics, anticipating risk, and collaborating with Clinical Operations, Regulatory, Safety, and other partners to keep trials inspection-ready and continuously improving. You will also develop Clinical Quality team members embedded in programs and help shape an integrated, proactive clinical quality strategy that scales with the pipeline.

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; collaboratively author standard operating procedures and related documents; monitor regulatory changes and assess impact to programs; provide guidance and mentorship to clinical quality staff assigned to clinical programs and supporting study teams.
• Vendor Quality Oversight: Partner with vendor management to update Quality Agreement templates; develop a program and processes for quality oversight and accountability of CROs and other vendors and develop and report quality metrics for CROs and critical clinical vendors.
• Quality Events, Audits & Inspections: Review and approve deviations, investigations, and CAPAs; lead or participate in audits and regulatory inspections; drive inspection readiness at local and global levels.

Qualifications

• Bachelor’s degree in a scientific field required; advanced scientific degree a plus
• 10+ years industry experience directly managing GCP/GPvP QA activities, audits, inspections, CAPAs, and risk management for multinational clinical programs and trials
• Must have worked within Sponsor organization though can be in combination with academic and/or CRO experience
• In-depth knowledge of quality, compliance, risk management, clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements
• Experience mentoring and directing members of quality and clinical operations teams
• Experience working in a team across multiple functional areas (e.g., CMC / GMP Quality, Data Management, Biostats, Safety, Clinical Supply)
• Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to create solutions and enable decisions
• Self-motivated and able to work autonomously, as well as a member of a high-functioning and collaborative team
• The physical and mental requirements include regular use of a computer and office equipment, clear communication, and occasional movement; comfortable with screen work and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Education

• Bachelor’s degree in a scientific field required; advanced scientific degree a plus

Additional Requirements

• The physical and mental requirements of the role include regular use of a computer and office equipment, clear communication, and occasional movement. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.