Clinical Trial Lead

Argenx - San Francisco, CA

Full-time - Mid Level

San Francisco, CA

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 that clinical trials are executed within quality standards, timelines, and budgets, while adhering to regulatory requirements. This position may involve leading a Clinical Trial Team (CTT) or managing specific clinical trial responsibilities under the guidance of a CTT Lead. The CTL is expected to drive operational planning, global coordination, and implementation of assigned studies, ensuring effective collaboration among various stakeholders.

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 transparently 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 and milestones.
• Guide and oversee CROs and other 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 such as clinical protocols and training materials.
• Monitor data quality and completeness, proactively identifying and resolving issues.
• Partner with Site & Patient Engagement teams on 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
• Reasonable accommodation for applicants