Director, Clinical Quality - Program and Process Quality

Praxis Precision Medicines, Inc.

3h • Remote

About The Position

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.

Requirements

• 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 although 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 of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

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 vendor
• 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

Benefits

• At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans.
• We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.
• We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.
• Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!
• To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees