Praxis Precision Medicines, Inc. · 19 hours ago
Director, Clinical Quality - Program and Process Quality
United States
Full-time
Remote
Director/Executive
$190K/yr - $220K/yr
10+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Clinical Quality leader will oversee GCP quality culture across clinical programs, ensuring compliance and driving continuous improvement while mentoring team members.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
Responsibilities
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
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
Review and approve deviations, investigations, and CAPAs
Lead or participate in audits and regulatory inspections
Drive inspection readiness at local and global levels
Qualification
Required
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
Benefits
99% of the premium paid for medical, dental and vision plans.
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage.
We match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns.
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
H1B Sponsorship
Praxis Precision Medicines, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
2026-01-11
2026-01-07
Company data provided by crunchbase