Clinical Operations Development Lead

argenx

Multiple Locations
**
15 years leadership experience in clinical development
Global strategic drug development experience
Ich gcp guidelines and regulatory compliance knowledge
** The Clinical Operations Development Lead (CODL) at argenx is responsible for overseeing clinical activities for specific therapeutic indications, providing strategic input for clinical development, and ensuring the execution of trials aligns with regulatory and quality standards. The role requires extensive leadership experience in clinical operations within the pharmaceutical or biotech industry, with a focus on managing budgets, timelines, and cross-functional teams. **

Job Summary

  • The Clinical Operations Development Lead drives operational strategy for clinical development across the entire asset lifecycle from First in Human to post-approval activities.
  • This role is accountable for managing clinical trial budgets, timelines, resources, and ensuring strict adherence to ICH-GCP and applicable regulations.
  • The successful candidate will lead cross-functional teams, manage risks, and provide strategic input to clinical development plans while fostering a culture of excellence and innovation.

Matching Summary

Match Score: 75

** The Clinical Operations Development Lead (CODL) at argenx is responsible for overseeing clinical activities for specific therapeutic indications, providing strategic input for clinical development, and ensuring the execution of trials aligns with regulatory and quality standards. The role requires extensive leadership experience in clinical operations within the pharmaceutical or biotech industry, with a focus on managing budgets, timelines, and cross-functional teams. **

Skills & Requirements

Must-have

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

Nice-to-have

  • Rare disease or auto-immune trial background
  • Experience with outsourced clinical models
  • Strong stakeholder management skills
  • Proactive problem-solving abilities
  • Coaching and mentoring 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
  • Proven experience overseeing CROs and collaborators in global settings

Work Rights

Not specified

Tailored Resume

Cover Letter