Global Clinical Operations Strategy Lead

argenx SE; Oost-Vlaanderen; On-site; EUR 90,000 - 120,000; Full time

Job summary

argenx SE is seeking a Clinical Operations Development Lead (CODL) in Belgium, Oost-Vlaanderen. This key position oversees clinical activities for specific therapeutic indications and provides strategic input across the development lifecycle from First in Human studies to post-approval activities.

The ideal candidate has extensive leadership experience in clinical development, strong communication skills, and a solid background in global drug development, ensuring compliance and successful execution of clinical trials.

Qualifications

• Minimum of 15 years of leadership experience in clinical development.
• Experience in overseeing CROs and collaborators in an outsourced model.
• Knowledge of ICH-GCP guidelines and applicable regulatory requirements.

Responsibilities

• Manage clinical trial budgets, timelines, and resources.
• Drive operational risk management and problem solving.
• Ensure compliance with quality standards and regulations.
• Lead the Clinical Development Plan in collaboration with IDT.
• Support audit and inspection readiness of assigned trials.

Skills

Leadership

Communication skills

Interpersonal skills

Stakeholder management

Problem-solving

Organizational skills

Team-building

English proficiency

Education

Bachelor’s or master’s degree in a medical or para-medical field

Job description

argenx SE is seeking a Clinical Operations Development Lead (CODL) in Belgium, Oost-Vlaanderen. This key position oversees clinical activities for specific therapeutic indications and provides strategic input across the development lifecycle from First in Human studies to post-approval activities.

The ideal candidate has extensive leadership experience in clinical development, strong communication skills, and a solid background in global drug development, ensuring compliance and successful execution of clinical trials.