Clinical Trial Lead

Argenx - Dallas, TX

Full-time - Senior

Dallas, TX

Administrative and Support Services

About the position

The Clinical Trial Lead (CTL) at argenx is a pivotal role responsible for overseeing the operational deliverables of clinical studies from the Final Protocol Concept Sheet to the Clinical Study Report (CSR). The CTL provides strategic insights and cross-functional leadership to ensure the successful execution of clinical trials within quality standards, timelines, and budget constraints. This position requires a strong operational mindset and the ability to connect people and processes to deliver innovative solutions for autoimmune patients.

Responsibilities

• Lead cross-functional execution of assigned global clinical trials from preparation until closure.
• Establish and lead the cross-functional Clinical Trial Team (CTT) in partnership with the Lead Trial Physician if assigned as CTT Lead.
• Ensure clinical trials are executed according to protocol requirements, trial plans, and applicable regulations.
• Set expectations and communicate clearly to motivate CTT members and external partners.
• Accountable for the delivery of global trials within agreed timelines and budget.
• Oversee cross-functional planning and track study progress, proactively managing trial deliverables.
• Guide and oversee CROs and vendors to ensure contractual obligations are met.
• Drive risk identification and mitigation, suggesting solutions and leading contingency planning.
• Ensure accurate trial budget management and timely management of scope changes.
• Develop trial-related materials and ensure vendor systems are configured according to protocol requirements.
• Oversee the country and site feasibility process and ensure cross-functional alignment.
• Monitor data quality and proactively identify and resolve issues.
• Partner with Site & Patient Engagement for recruitment and retention strategies.

Requirements

• Bachelor's degree or equivalent experience.
• Minimum of 8 years of experience in Clinical Operations, including management and oversight of CROs and vendors.
• Global clinical trial management experience required.
• Strong knowledge of ICH-GCP and other applicable regulations.
• Experience with tools and systems for managing clinical studies (e.g., MS Project, CTMS, TMF).

Nice-to-haves

• Biotech experience is a plus.
• Experience in rare disease, autoimmune, and/or oncology clinical trials is a plus.

Benefits

• Inclusive work environment
• Equal opportunity employer
• Support for reasonable accommodation requests