Clinical Operations Development Lead

Argenx

Not specified
15 years leadership experience in clinical development
Global strategic drug development expertise
Ich gcp guidelines and regulatory compliance knowledge
The Clinical Operations Development Lead (CODL) at Argenx plays a crucial role in overseeing clinical activities for specific therapeutic indications, managing trial budgets, timelines, and resources while ensuring compliance with regulatory standards. The ideal candidate will have extensive leadership experience in clinical development within the pharmaceutical or biotech industry, particularly with rare diseases or autoimmune conditions. ###

Job Summary

  • The role oversees clinical activities across the asset lifecycle from First in Human studies through registration and post-approval phases.
  • Candidates must manage clinical trial budgets, timelines, and resources while driving operational risk management and cross-functional implementation.
  • The position requires leading the Indication Development Team to ensure effective decision-making aligned with company objectives and goals.

Matching Summary

Match Score: 85

The Clinical Operations Development Lead (CODL) at Argenx plays a crucial role in overseeing clinical activities for specific therapeutic indications, managing trial budgets, timelines, and resources while ensuring compliance with regulatory standards. The ideal candidate will have extensive leadership experience in clinical development within the pharmaceutical or biotech industry, particularly with rare diseases or autoimmune conditions. ###

Skills & Requirements

Must-have

  • 15 years leadership experience in Clinical Development
  • Global strategic drug development expertise
  • ICH GCP guidelines and regulatory compliance knowledge
  • CRO management and outsourced model oversight
  • Budget and timeline accountability for clinical trials

Nice-to-have

  • Rare disease or auto-immune clinical trial background
  • Experience with innovative trial designs
  • Strong stakeholder management in diverse teams
  • Proven problem solver handling conflicts effectively

Key Requirements

  • Bachelor's or Master's degree in medical or para-medical field
  • Minimum 15 years of leadership experience in Clinical Development
  • Thorough knowledge of ICH GCP guidelines and applicable regulations

Work Rights

Not specified

Tailored Resume

Cover Letter