Clinical Operations Development Lead

Job Summary

To support the expansion of Global Clinical Trial Operations, the full-time Clinical Operations Development Lead will oversee clinical activities for specific therapeutic indications, co-lead the Clinical Development Team, manage clinical trial budgets, and ensure compliance with timelines and quality standards, all while working remotely.

Key responsibilities

• Oversees clinical trial budgets and contributes to timeline and resource planning, ensuring alignment with the Clinical Development Plan
• Co-leads the Clinical Development Team and acts as the primary contact for all clinical-related activities within assigned indications
• Identifies and mitigates risks to ensure clinical trials are executed according to objectives, goals, and regulatory compliance

Required qualifications

• Bachelor's degree in a medical or para-medical field; PhD is a plus
• Minimum of 10 years of leadership experience in Clinical Development, including trial management
• Experience working with CROs and vendors in an outsourced model
• Background in rare diseases or autoimmune clinical trials is advantageous
• Thorough knowledge of ICH GCP guidelines and relevant regulatory requirements