Clinical Operations Development Lead

Argenx - Remote, OR

Full-time - Senior

Remote, OR

Administrative and Support Services

About the position

The Clinical Operations Development Lead (CODL) at argenx is responsible for overseeing clinical activities within specific therapeutic indications for assets, co-leading the Clinical Development Team (CDT) alongside the Medical Development Lead (MDL). This role involves strategic input into the Clinical Development Plan (CDP), ensuring effective execution of clinical programs, managing budgets, timelines, and resources, and serving as the primary contact for clinical activities throughout the lifecycle of a compound. The CODL plays a crucial role in driving clinical trial strategies and ensuring compliance with regulatory standards while fostering collaboration across various functional teams.

Responsibilities

• Oversee clinical activities within specific therapeutic indications for an asset or across all indications.
• Co-lead the Clinical Development Team (CDT) with the Medical Development Lead (MDL).
• Create and ensure execution of the Clinical Development Plan (CDP) in collaboration with the MDL, PM, and other CDT representatives.
• Act as the primary point of contact for all clinical related activities for a given indication or across asset indications.
• Lead CDT meetings and ensure effective communication and documentation of outcomes.
• Identify risks related to team goals, timelines, or budget and drive mitigation strategies.
• Collaborate with Clinical Trial Managers (CTMs) to ensure timely availability of clinical documents and trial execution.
• Participate in the selection and management of Clinical Research Organizations (CROs) and vendors.
• Review and provide input to regulatory documents and ensure audit readiness of clinical trials.
• Mentor and manage Clinical Trial Managers and/or Clinical Trial Associates.

Requirements

• Bachelor's degree or equivalent in medical or para-medical fields (Biology, Biomedical Sciences, Pharmacy, Veterinary, etc.).
• Minimum of 10 years of leading experience in Clinical Development.
• Proven experience in a relevant global leadership position in the pharmaceutical/biotech industry.
• Strong knowledge of ICH GCP guidelines and regulatory requirements.
• Excellent written and verbal communication skills in English.

Nice-to-haves

• PhD degree in a relevant field.
• Experience in rare disease and/or autoimmune clinical trials.
• Line management experience.

Benefits

• Inclusive work environment
• Equal opportunity employer
• Support for reasonable accommodation requests