Clinical Operations Development Lead

argenx

93d

About The Position

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. For the expansion of our Global Clinical Trial Operations team, argenx is looking for a Clinical Operations Development Lead.

Requirements

• Bachelor’s degree or University degree – medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience.
• Minimum of 10 years of leading experience in Clinical Development (monitoring, local and global/international trial management).
• Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
• Strong interpersonal and stakeholder management skills.
• Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements and guidelines.
• Strong organizational skills, able to manage multiple and varied tasks and prioritize workload.

Nice To Haves

• PhD degree is a plus.
• Experience in working in an outsourced model, including overseeing CROs and vendors.
• Rare disease and/or auto-immune clinical trial background is a plus.
• Line management experience is a plus.

Responsibilities

• 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.
• Builds a strong CDT by working with respective functional heads to assign CDT representatives from the involved functional areas.
• 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 and to discuss options to resolve issues and mitigate risks.
• 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 a Subject Matter Expert.
• Ensures audit/inspection readiness of the assigned program/trials.
• Sets expectations, communicates clearly, and motivates the CDT team members.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees