[Hiring] Clinical Operations Development Lead @argenx

Role Description

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.

For the expansion of our Global Clinical Trial Operations team, argenx is looking for a Clinical Operations Development Lead.

Key Accountabilities/Responsibilities

• The Clinical Operations Development Lead (CODL) is responsible for the oversight of 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) with the Medical Development Lead (MDL) and co-owns the Clinical Development Plan (CDP).
• Works with the MDL and the Project Manager (PM) to ensure 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 involved functional areas.
• Oversees clinical trial budgets, contributes to timeline and resource requirements, and provides input to financial CDT planning.
• Partners with the PM to review status and impact of changes, discuss options to resolve issues, and adjust plans accordingly.
• Ensures risks and mitigations are discussed in the team and reflected in applicable risk registries.
• Acts as the primary contact for the CDT and all CDP related activities for a given indication or across asset indications.
• Ensures cross-functional optimization of solutions and takes accountability for decisions.
• Contributes to CDT discussions as a Subject Matter Expert.
• Ensures audit/inspection readiness of the assigned program/trials and supports audits and inspections.

Skills and Competencies

• Excels in leadership and establishing effective internal and external working relationships.
• Global Strategic Drug Development experience and understanding.
• Strong interpersonal and stakeholder management skills.
• Proven Clinical Operations experience in a relevant global leadership position in the pharmaceutical/biotech industry.
• Pro-active problem solver with demonstrated ability to identify and resolve issues.
• Strong organizational skills, able to manage multiple tasks and prioritize workload.
• Strong people management and leadership skills.
• Excellent written and verbal communication skills in English.
• Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements.

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

Compensation and Benefits

• The annual base salary hiring range for this position is $212,000.00 - $291,500.00 USD.
• This job is eligible to participate in short-term and long-term incentive programs.
• Includes a comprehensive benefits package, including retirement savings plans and health benefits.

Company Description

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.