Clinical Operations Development Lead

Job Summary

Leading the operational strategy for a franchise, the full-time remote Franchise Clinical Operations Development Lead (CODL) will oversee clinical development plans, manage Clinical Operations Development Leads, and ensure compliance with regulatory standards while driving the execution of clinical trials across multiple indications.

Key responsibilities

• Oversee the creation and execution of Clinical Development Plans (CDPs) for all indications within the franchise, ensuring alignment with timelines, budgets, and quality standards
• Act as the senior point of contact for clinical activities within the franchise, collaborating with asset teams and managing risks and mitigations
• Lead and mentor a team of Clinical Operations Development Leads, ensuring effective communication and operational excellence across the franchise

Required qualifications

• Bachelor's degree in a medical or para-medical field; PhD is a plus
• Minimum of 15 years of experience in Clinical Development, including trial management and oversight of CROs
• Proven leadership experience in the pharmaceutical or biotech industries
• Strong knowledge of ICH GCP guidelines and regulatory requirements
• Experience in managing clinical trials related to rare diseases or autoimmune conditions