Franchise Clinical Operations Development Lead (CODL)

The Franchise Clinical Operations Development Lead (CODL) at argenx is a pivotal role focused on the strategic planning and execution of clinical operations for various indications within a franchise. Argenx is a biotech company dedicated to transforming immunology and developing medicines for autoimmune diseases, with a strong focus on its first-in-class neonatal Fc receptor blocker, VYVGART. The main day-to-day responsibilities of the Franchise CODL include overseeing the Clinical Operations Development Leads (CODLs) assigned to specific indications, ensuring that all clinical activities align with timelines, budgets, and quality standards. This role involves creating and executing Clinical Development Plans (CDPs) for all indications, collaborating with various teams, and acting as a senior point of contact for clinical activities. The Franchise CODL also manages risks and mitigations at the franchise level, ensures the sharing of knowledge and best practices, and supports the resolution of trial management issues. Additionally, this role involves overseeing budgets, timelines, and resource requirements, as well as supporting audits and inspections. To excel in this role, candidates must have a proven track record in leadership positions within Clinical Operations in the pharmaceutical or biotech industries. Essential qualifications include experience in planning and executing clinical development plans and clinical trials, as well as a background in line management. Strong organizational skills and the ability to build and lead a team with diverse skill sets are also crucial. Nice-to-have skills include the ability to establish effective internal and external working relationships and communication, embedding the argenx values. The role offers opportunities for growth and development, with a focus on mentoring and enabling the growth of assigned staff. The location and team dynamics are not specified, but the role involves collaboration with various stakeholders, including Corporate Development, Science, Patient Advocacy Groups, and Medical Affairs. What the role asks for: - Proven track record in leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries. - Experience in planning and execution of clinical development plans and clinical trials. - Experience in building and leading a team with a variety of skill sets. - Knowledge of planning and execution of clinical development plans and clinical trials. - Ability to establish effective internal and external working relationships and communication, embedding the argenx values.