Director, Clinical Quality - Program and Process Quality
Praxis Precision Medicines, Inc.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
- 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
Qualifications and Key Success Factors
- 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.
Compensation & 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.
Company Overview
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.
Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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