Clinical Operations Development Lead

About the role

argenx is expanding its Global Clinical Trial Operations team to support the development of its pipeline of differentiated assets, including VYVGART, a first-in-class neonatal Fc receptor blocker for gMG. The Clinical Operations Development Lead will oversee clinical activities for a specific therapeutic indication or across multiple indications.

Responsibilities

• Oversee clinical activities for a specific therapeutic indication or across multiple indications.
• Co-lead the Clinical Development Team (CDT) and co-own the Clinical Development Plan (CDP).
• Work with the Asset Strategy Team (AST) to ensure all relevant information from all functions is brought to the table.
• Build a strong CDT by assigning representatives from involved functional areas.
• Create the CDP in collaboration with the Medical Development Lead (MDL) and other CDT representatives, ensuring it describes the clinical development strategy and is consistent with the Target Product Profile (TPP).
• Ensure the CDP is endorsed by the AST and the Development Management Committee (DMC) and is executed within agreed timelines and budget.
• Lead the CDT meetings, focusing on strategic content, and ensure outcomes, actions, and conclusions are agreed upon.
• Provide input to the Objectives, Goals, Strategies and Measures (OGSM) and ensure clinical trials are executed according to the CDP and OGSMs.
• Identify and mitigate risks, reflect them in risk registries, and drive their mitigation.
• Drive the timely production of a qualitative Clinical Trial Concept Sheet and collaborate with CTMs and their respective CTTs to ensure timely availability of qualitative documents.
• Collaborate with the CSSC to have the initial list of countries and sites ready, and ensure the AST and CDT are kept informed on the final selection.
• Support the CTT with issue resolution and participate in the CRO and vendor selection and management process.
• Act as the primary point of escalation for resolution of trial management and operational issues within assigned indication(s).
• Ensure audit/inspection readiness of the assigned program/trials and support audits and inspections.
• Ensure audit/inspection readiness of the assigned program/trials and support audits and inspections.
• Support continuous improvement processes and consistency by sharing lessons learned across trials within the assigned therapeutic indication, across indications, and across compounds.
• Set expectations, communicate transparently, and motivate the CDT team members and respective CTMs to achieve clinical goals in line with OGSM and argenx' cultural pillars.
• Act as a line manager of CTMs and/or CTAs, including interviewing candidates, on-boarding new direct reports, goal setting and review, mentoring, and enabling the growth and development of assigned staff.

Requirements

• 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 (monitoring, local and global/international trial management).
• Experience in working in an outsourced model, including overseeing CROs and vendors.
• Rare disease and/or auto-immune clinical trial background is a plus.