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Clinical Operations Development Lead @argenx US Inc

[Hiring] Clinical Operations Development Lead @argenx US Inc

Mar 14, 2025 - argenx US Inc is hiring a remote Clinical Operations Development Lead. đź’¸ Salary: unspecified. đź“ŤLocation: USA.

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Role Description

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is looking for a Clinical Operations Development Lead.

  • The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset or across all indications for an asset.
  • Co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP) with the Medical Development Lead (MDL).
  • Works with the MDL and the Project Manager (PM) to ensure that all relevant information from all functions within the Asset Strategy Team (AST) and CDT are brought to the table.
  • Drives the execution of the clinical program in collaboration with the CDT members according to the CDP.
  • Oversees the clinical trial budgets, contributes to timeline and resource requirements, and provides input to the financial CDT planning.
  • Partners with the PM to review status and impact of change, discuss options to resolve issues, and adjust plans accordingly.
  • Acts as primary contact person for the CDT and all CDP related activities for a given indication or across asset indications.
  • Ensures the cross-functional optimization of solutions integrating contributions on complex matters.
  • Contributes to CDT discussions as Subject Matter Experts.
  • Ensures audit/inspection readiness of the assigned program/trials and supports audits and inspections.

Qualifications

  • Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience.
  • PhD degree is a plus.
  • Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management).
  • Experience in working in an outsourced model, including overseeing CROs and vendors.
  • Rare disease and/or auto-immune clinical trial background is a plus.

Requirements

  • Global Strategic Drug Development experience and understanding.
  • Strong interpersonal and stakeholder management skills.
  • Pro-active problem solver with demonstrated ability to identify and resolve issues.
  • Strong organizational skills, able to manage multiple tasks and prioritize workload.
  • Excellent written and verbal communication skills, acting globally in a culturally diverse dynamic team.
  • Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.

Benefits

  • Inclusive environment with equal consideration for employment without discrimination.
  • Support for reasonable accommodation in the application and interview process.

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Back to Remote jobs  >   All others
Clinical Operations Development Lead @argenx US Inc
All others
Salary đź’¸ unspecified
Remote Location
USA
Job Type full-time
Posted Mar 14, 2025
Apply for this position Unlock 55,087 Remote Jobs
️
đź“Ť Be aware of the location restriction for this remote position: USA
‼ Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.
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