Clinical Operations Development Lead

Argenx - San Francisco, CA

Full-time - Senior

San Francisco, CA

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 across indications. The CODL plays a crucial role in driving clinical trial strategies and ensuring compliance with regulatory standards while fostering collaboration among cross-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 and Project Manager (PM).
• Manage clinical trial budgets and provide input on timelines and resource requirements.
• Identify risks and ensure they are reflected in risk registries, driving mitigation strategies.
• Act as the primary point of contact for all clinical-related activities for assigned indications.
• Ensure consistency and efficiency in trial setup and conduct across different trials.
• Collaborate with Clinical Trial Managers (CTMs) to ensure timely availability of necessary documents for clinical programs.
• Participate in the selection and management of Clinical Research Organizations (CROs) and vendors.
• Support continuous improvement processes and ensure audit readiness of assigned programs.

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 Clinical Operations experience in a global leadership position within the pharmaceutical/biotech industry.
• Strong interpersonal and stakeholder management skills.
• Thorough knowledge of ICH GCP guidelines and other applicable regulatory requirements.

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