Clinical Operations Development Lead

Job Summary

To support the development of innovative therapies for autoimmune diseases, the full-time Clinical Operations Development Lead will oversee clinical activities for specific therapeutic indications, manage trial budgets and timelines, and provide strategic input throughout the clinical development lifecycle, with opportunities for remote work.

Key responsibilities

• Provide operational expertise and strategic input to the Clinical Development Plan in collaboration with the Indication Development Team
• Ensure execution of clinical trials aligns with timelines, budgets, quality standards, and regulatory requirements
• Identify and mitigate operational risks while serving as the primary contact for all clinical-related activities at the indication level

Required qualifications

• Bachelor's or master's degree in a medical or para-medical field or equivalent experience
• Minimum of 15 years of leadership experience in Clinical Development, including global/international trial management
• Proven experience in overseeing CROs and collaborators in an outsourced model
• Strong background in rare disease and/or autoimmune clinical trials is a plus
• Thorough knowledge of ICH GCP guidelines and applicable regulatory requirements