Clinical Quality Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Clinical Quality Lead is responsible for driving towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing, by providing GCP oversight for an argenx asset (applicable based on assignment), acting as GCP SME, supporting audit and inspection planning and execution, and manage clinical quality event investigations and remediation.

The Clinical Quality Lead will also oversee relationship and performance of clinical partners vendors/suppliers, and act as GCP Quality Point of Contact (POC) for assigned Business Partners.

ROLES AND RESPONSIBILITIES

• Serve as the primary Quality point of contact for assigned clinical trials

• Guide the Clinical Trial Team (CTT) to ensure clinical trials are conducted in compliance with GCPs, regulatory requirements, and argenx processes

• Lead the GCP quality oversight for assigned clinical trials, collaborating closely with CTT(s) to uphold high-quality standards

• Manage the clinical trial audit programs, including leading the audit site selection process for study-specific audit plans in collaboration with CTT(s), and ensuring timely audit conduct, reporting, review, and closeout in accordance with argenx processes

• Oversee or lead the qualification/re-qualification of vendors as necessary

• Participate in and lead audits to maintain compliance and quality

• Work with CTT(s) to produce GCP quality system metrics for real-time quality monitoring and reporting (e.g., audits, deviations, CAPAs), and conduct trend analysis for management reporting

• Drive the investigation of trial quality events and define necessary corrective and preventive measures

• Lead clinical trial inspection readiness activities to ensure preparedness

• Provide QA input during the creation/revision of argenx clinical procedural documents for GCP compliance

• When assigned as “QA Approver” in ARGO or PhoeniQS, act as QA approver for GCP area.

• Act as a delegate for R&D Quality head for the Document Review Committee (DRC)

• Participate/lead in regulatory inspections

• Oversee the relationship and performance of clinical partners/vendors to maintain quality standards

• Support and own key GCP Quality processes per assignment and offer solutions/improvement from a continuous improvement mindset

• Provide metrics and trends for continuous improvement, sharing lessons learned and best practices among other CTT(s).

• Ability to mentor junior quality leads upon delegation by the R&D quality head.

SKILLS AND COMPETENCIES

• In‐depth knowledge of Clinical Trial related US and EU regulations and ICH GCP Guidelines

• Preferred: Knowledge of global pharmacovigilance regulations

• Ability to create a comprehensive study quality oversight plan and audit program and lead the execution

• Proven capability to establish and maintain effective relationships with both internal and external stakeholders

• Demonstrated ability to thrive in a dynamic environment within a rapidly growing biotech company, effectively managing challenging timelines.

• Ability to influence without direct leadership: motivate and educate the clinical study team on clinical quality aspects

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• MS Degree

• Minimum 7 years clinical trial experience

• Minimum 5 years quality assurance experience

• FDA, EMA, MHRA, PDMA Inspection experience

LI-Onsite

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For applicants in the United States: The annual base salary hiring range for this position is $152,000.00 - $209,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.