15 years clinical development leadership experience
Global strategic drug development expertise
Ich gcp regulatory compliance knowledge
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The Clinical Operations Development Lead (CODL) at argenx is responsible for overseeing clinical activities for specific therapeutic indications, managing trial operations, budgets, and timelines, and ensuring compliance with regulations. The ideal candidate should possess extensive leadership experience in clinical operations within the pharmaceutical or biotech industry, with strong problem-solving and interpersonal skills.
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Job Summary
The Clinical Operations Development Lead drives strategy for clinical development across the asset lifecycle from First in Human through post-approval activities.
This role is accountable for managing clinical trial budgets, timelines, resources, and ensuring execution aligns with ICH-GCP and applicable regulations.
The successful candidate will lead the Indication Development Team, fostering a culture of humility, co-creation, and excellence while mentoring Clinical Trial Leads.
Matching Summary
Match Score: 75
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The Clinical Operations Development Lead (CODL) at argenx is responsible for overseeing clinical activities for specific therapeutic indications, managing trial operations, budgets, and timelines, and ensuring compliance with regulations. The ideal candidate should possess extensive leadership experience in clinical operations within the pharmaceutical or biotech industry, with strong problem-solving and interpersonal skills.
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Skills & Requirements
Must-have
15 years clinical development leadership experience
Global strategic drug development expertise
ICH GCP regulatory compliance knowledge
CRO management and oversight skills
Clinical trial budget and timeline management
Nice-to-have
Rare disease or autoimmune trial background
Experience with outsourced operational models
Strong stakeholder management capabilities
Proven problem-solving 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 and regulatory requirements