Global Clinical Operations Strategy Lead

argenx SE

Oost-Vlaanderen

Sur place

EUR 90 000 - 120 000

Plein temps

14 jours+
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Résumé du poste

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.

Responsabilités

  • 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.

Connaissances

Leadership
Communication skills
Interpersonal skills
Stakeholder management
Problem-solving
Organizational skills
Team-building
English proficiency

Formation

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

Description du poste

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.

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