Clinical Operations Development Lead
5 days ago
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.
- 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.
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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