Franchise Clinical Operations Lead – Strategy & Execution

argenx; Belgique; Sur place; EUR 230 000 - 316 000; Plein temps

Résumé du poste

argenx is seeking a Franchise Clinical Operations Development Lead (CODL) to strategize, plan, and execute the operational path for multiple indications within a franchise from first-in-human studies through authorization and commercialization. The CODL will line-manage CODLs, and coordinate with MDL, PM and CDT to deliver CDPs and ensure timelines and budgets are met.

The role requires extensive leadership experience in Clinical Operations, CRO management, and regulatory compliance, with a

Qualifications

• Minimum 15 years leading experience in Clinical Development.
• Experience in outsourced model and overseeing CROs/vendors.
• Budgeting, risk management and cross-functional leadership.
• Strong knowledge of ICH-GCP guidelines and regulatory requirements.

Responsabilités

• Oversee CODLs and ensure timelines, budget and quality.
• Create and endorse the CDP for the franchise.
• Act as senior contact for clinical activities across indications.
• Lead risk management and escalation at franchise level.
• Mentor and develop CODLs and CTMs across teams.

Connaissances

Leadership

Clinical Development

Trial management

CRO management

Budgeting

Formation

Bachelor’s degree

PhD preferred

Description du poste

argenx is seeking a Franchise Clinical Operations Development Lead (CODL) to strategize, plan, and execute the operational path for multiple indications within a franchise from first-in-human studies through authorization and commercialization. The CODL will line-manage CODLs, and coordinate with MDL, PM and CDT to deliver CDPs and ensure timelines and budgets are met.

The role requires extensive leadership experience in Clinical Operations, CRO management, and regulatory compliance, with a