Clinical Operations Development Lead

3 weeks ago


Dallas, Texas, United States Argenx Full time
Job Description

Job Summary:

The Clinical Operations Development Lead - Franchise will be responsible for leading the clinical operations strategy and execution for a specific franchise within the company. This role will oversee the development and implementation of clinical development plans, manage clinical trial budgets and timelines, and ensure compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement clinical development plans for the franchise, in collaboration with cross-functional teams
  • Manage clinical trial budgets and timelines, ensuring timely and within-budget delivery
  • Oversee the resource requirements for trial operations within the franchise, ensuring timely and efficient onboarding of resources
  • Ensure compliance with regulatory requirements, including ICH-GCP guidelines and other applicable legislation
  • Collaborate with stakeholders outside of Clinical and R&D, including Corporate Development, Science, Patient Advocacy Group, Medical Affairs, and others
  • Act as a senior point of contact for all clinical-related activities for the franchise, providing strategic input and oversight
  • Lead and manage a team of Clinical Operations Development Leads (CODLs) assigned to indications within the franchise
  • Provide input to relevant Objectives, Goals, Strategies, and Measures (OGSMs), ensuring clinical trials are executed according to clinical development plans and OGSMs
  • Participate in the Clinical Research Organization (CRO) and vendor selection and management process, as needed
  • Act as a point of escalation for resolution of trial management and operational issues within the franchise
  • Review and provide input to overarching clinical program/indication documents, such as Investigator Brochure (IB), Pediatric Investigation Plan (PIP), FDA/PMDA/EMA, and other regulatory critical documents

Requirements:

  • Bachelor's degree or University degree in a medical or para-medical field (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.) or equivalent by experience
  • Minimum of 12 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
  • Strategy as well as execution for clinical development
  • Change and risk management
  • Budget financial acumen
  • Rare disease and/or auto-immune clinical trial background relevant to the franchise

What We Offer:

At Argenx, we strive to create a welcoming and inclusive environment. We are proud to be an equal opportunity employer and welcome applications from diverse candidates.



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