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 registration and post-approval phases

Job Summary

  • The role involves overseeing clinical activities across the asset lifecycle from First in Human studies through registration and post-approval phases.
  • Candidates must demonstrate strong leadership skills to manage budgets, timelines, and resources while driving operational risk management.
  • The position requires a minimum of 15 years of leadership experience in clinical development within the pharmaceutical or biotech industry.

Matching Summary

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

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 vendor 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
  • Proactive problem solving and risk mitigation
  • Coaching and mentoring clinical team members

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
  • Experience working in an outsourced model with CRO oversight

Work Rights

Not specified

Tailored Resume

Cover Letter