Senior Director, Clinical Quality

Praxis Precision Medicines, Inc.; United States; Remote; USD 200,000 - 240,000; Full time

Job summary

Join Praxis as the Director of Clinical Quality Assurance to lead GCP compliance and enhance clinical trial quality standards. This pivotal role involves developing quality systems, managing inspections, and fostering cross-functional collaboration. Ideal candidates possess extensive clinical research experience and a strong commitment to excellence in quality management.

Benefits

99% premium cost covered for medical, dental, and vision plans

Bonus program structured to pay quarterly

401k plan with 100% match up to 6%

Unlimited PTO plus generous extended family leave

Eligibility for equity awards and Employee Stock Purchase Plan

Qualifications

• Minimum of 10 years of experience in a GCP practice area.
• Strong knowledge of clinical trial methodology and regulatory compliance.
• Excellent oral and written English communication skills.

Responsibilities

• Lead the development of Clinical Quality Management System procedures.
• Manage inspection readiness activities and audits.
• Collaborate with clinical operations to establish performance metrics.

Skills

Quality Management

GCP Guidelines

Negotiation

Inspection Readiness

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

Job description

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

The Opportunity
Join Praxis as the Director of Clinical Quality Assurance and take the helm in creating a culture of excellence and accountability! Reporting directly to the Vice President of Quality, this pivotal position is a unique opportunity to shape the future of clinical trials, ensuring unwavering compliance with Good Clinical Practice (GCP) regulations and standards. We are looking for a strategic thinker and hands-on leader who possesses extensive experience in quality management within clinical research. You’ll spearhead the development and implementation of consistent, standardized quality systems, working collaboratively with cross-functional clinical trial teams to embed a quality-by-design infrastructure across all studies.

You will play a critical role in overseeing and enhancing Quality Assurance (QA) activities and ensuring relentless inspection readiness for Praxis-sponsored clinical trials, from first-in-human studies to commercial marketing authorization. Your expertise will be invaluable as you engage with both internal teams and external partners—including vendors, consultants, and service providers—to drive optimal quality performance and foster meaningful relationships. If you’re dedicated, visionary, and ready to make a significant impact in the clinical landscape, we want you to help us set the gold standard for clinical quality management at Praxis! Your contributions will directly influence our commitment to executing high-quality clinical trials, ultimately advancing the health and well-being of patients around the globe.

Primary Responsibilities
In partnership with Clinical and Quality management, drive strategy and execution of the following:

• Lead the development, management and maintenance of Clinical aspects of Praxis’ Quality Management System procedures and related processes for continuous improvement
• Lead inspection readiness activities and provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable. Assist with inspection preparedness of investigator sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies.
• Manage direct reports and consultants, as needed, in the pursuit of Clinical Quality Assurance objectives
• Partner with clinical study teams to coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary
• Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams
• Author and maintain QA Standard Operating Procedures (SOPs). Support management of other functional area SOPs
• In collaboration with functional area leads, support training oversight
• Lead process improvement projects as needed
• Provide Clinical Quality Assurance SME to reviews of clinical protocols, amendments, Clinical Study Reports, and other clinical trial-related documents
• Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Perform and follow-up on audits of CROs, external laboratories, and clinical trial sites in collaboration with QMS Management
• Collaborate with Clinical Operations Leads to establish performance and quality metrics for the study and report metrics that drive quality and efficiency
• Provides leadership for investigation of critical compliance issues (scientific misconduct and serious breach) and escalates as appropriate to internal and external partners, including regulators, as appropriate
• Establish key vendor oversight plans and processes (e.g., Clinical Study Oversight Plan, Quality Plan, Co-monitoring, toolkit, etc.

Qualifications and Key Success Factors

• Bachelor's degree in a scientific discipline or equivalent experience
• Demonstrating strong negotiation skills and flexibility; excel in providing solution-based approaches to emerging challenges while simultaneously managing multiple project issues amid time constraints, incomplete information, or unexpected events.
• Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
• Expertise with applicable GCP guidelines. Strong knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials. Formal training in clinical research methods is a plus.
• Experience with Veeva platform highly preferred
• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
• Must possess excellent oral and written English communication skills.
• High integrity and ability to build relationships, work collaboratively and bring out the best in others, intellectually and interpersonally, on a cross-functional team, within the department, company, and across vendors.
• Demonstrates innovative thinking, with a curious and with an entrepreneurial spirit; can thrive in an agile environment.
• Business travel to be ~25% as required. Ability to travel domestically and internationally.

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.

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this 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.

$200,000 - $240,000 USD

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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