Clinical Operations Development Lead

argenx

15 years leadership experience in clinical development
Global strategic drug development experience
Ich gcp guidelines and regulatory compliance knowledge
The role involves overseeing clinical activities across the asset lifecycle from First in Human studies through post-approval development

Job Summary

  • The role involves overseeing clinical activities across the asset lifecycle from First in Human studies through post-approval development.
  • Candidates must demonstrate strong leadership skills to manage clinical trial budgets, timelines, and cross-functional team performance.
  • The position requires acting as the primary point of contact for operational clinical activities and driving risk mitigation strategies.

Matching Summary

The role involves overseeing clinical activities across the asset lifecycle from First in Human studies through post-approval development.

Skills & Requirements

Must-have

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

Nice-to-have

  • Rare disease and auto-immune trial background
  • Experience with outsourced operational models
  • Strong stakeholder management in diverse teams
  • Proven problem solver in complex environments

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

Work Rights

Not specified

Tailored Resume

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