Clinical Operations Development Lead

5 days ago


San Francisco, California, United States Argenx Full time
Job Summary

We are seeking a highly experienced Clinical Operations Development Lead to join our team at Argenx. As a key member of our Clinical Operations department, you will be responsible for leading the development and execution of clinical strategies for our franchise.

Key Responsibilities
  • Develop and implement clinical development plans for our franchise, ensuring alignment with business objectives and regulatory requirements.
  • Lead a team of Clinical Operations Development Leads, providing guidance and support to ensure successful execution of clinical trials.
  • Collaborate with cross-functional teams, including Medical Development, Project Management, and Clinical Development, to ensure seamless execution of clinical trials.
  • Develop and maintain relationships with external partners, including CROs and vendors, to ensure successful execution of clinical trials.
  • Provide strategic input to the development of clinical trial budgets and timelines, ensuring alignment with business objectives and regulatory requirements.
  • Oversee the audit and inspection readiness of our clinical trials, ensuring compliance with regulatory requirements.
  • Support the development of clinical trial protocols, informed consent forms, and other regulatory documents.
  • Stay up-to-date with regulatory requirements and industry trends, ensuring compliance and best practices in clinical operations.
Requirements
  • Minimum 12 years of experience in clinical development, with a strong background in clinical operations.
  • Proven track record of leading clinical development teams and executing clinical trials.
  • Strong knowledge of regulatory requirements, including ICH GCP guidelines.
  • Excellent communication and leadership skills, with the ability to work effectively in a cross-functional team environment.
  • Strong analytical and problem-solving skills, with the ability to identify and mitigate risks.
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines.
What We Offer

At Argenx, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment, where all employees feel valued and supported.



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