Clinical Operations Development Lead

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.

Key Accountabilities/Responsibilities:The Clinical Operations Development Lead (CODL) is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication CODL). Together with the Medical Development Lead (MDL), the CODL co-leads the Clinical Development Team (CDT) and co-owns the Clinical Development Plan (CDP).

As ad-hoc member of the Asset Strategy Team (AST), works with the MDL and the Project Manager (PM) to ensure that all relevant information from all functions within the AST and CDT are brought to the table.

A CDT kicks off as soon as preparations start for a First in Human (FIH) study (in the case of the first indication for a given compound) or when first clinical related discussions start for a new indication.

To build a strong CDT, the CODL works with the respective functional heads to assign CDT representatives from the involved functional areas.

During the start of the clinical related activities for a new asset, the AST meetings and the CDT meetings may be combined. The Target Product Profile (TPP), created by the AST (with input from the CDT), is used as the basis for the CDP. The CDT is responsible for the clinical development strategy, ensuring creation of the CDP and execution, once endorsed by the AST. As co-leader, the CODL drives the execution of the clinical program in collaboration with the CDT members and according to what is in the CDP.

The CODL oversees the clinical trial budgets, contributes to timeline and resource requirements and provides input to the financial CDT planning (created and maintained by the PM working with the Finance Business Partner). Hereto (s)he provides the PM with the estimates and updates of cost versus budget for key deliverables chosen to be integrated into the overarching Indication and Product plans. Informs the PM in case the timelines or budget deviate from projected. The CODL partners with the PM to review status and impact of change and to discuss with the team, options to resolve issues and mitigate risks and adjust the plans accordingly, which may be subject to governance endorsement.

Likewise, the CODL and PM partner to ensure that risks and mitigations are discussed in the team, reflected in the applicable risk registries, and translated into timely plan adjustment and action.

The CODL and the MDL keep the oversight and are the primary contact person for the CDT and all CDP related activities for a given indication (CODL) or across asset indications (X-indication CODL). These include the trial related activities as well as the clinical development strategy across the lifecycle of a compound, starting with the preparation of the FIH clinical trial throughout registration and post-approval clinical development activities. Hence, after completion of the Clinical Phase III program, CODL and MDL, in close collaboration with the CDT members, continue to be involved in the clinical related activities e.g., through...