Franchise Clinical Operations Development Lead (CODL)

Role: Franchise Clinical Operations Development Lead (CODL) overseeing clinical trial strategies and operations across multiple indications within a biopharma franchise, primarily in autoimmune or immunology areas. Objectives: lead the planning, execution, and management of clinical development from first-in-human to commercialization, ensuring alignment with timelines, budgets, quality standards, and regulatory requirements. Responsibilities: manage and mentor Clinical Operations Development Leads (CODLs), co-develop clinical development plans (CDPs), oversee vendor and CRO activities, ensure risk mitigation, and drive cross-indication knowledge sharing. Also responsible for budget and resource planning, audit readiness, and stakeholder collaboration across functions such as Medical, Regulatory, and Clinical Development. Qualifications: Bachelor’s degree (advanced degrees or PhD preferred), minimum 15 years’ leadership experience in global clinical development, including trial management and outsourcing models. Deep knowledge of ICH GCP, regulatory standards, and autoimmune or rare disease trial experience are preferred. Skills: strong leadership, strategic planning, problem-solving, organizational, and communication skills, with proven ability to build and lead multidisciplinary teams. High-value: leading multi-indication autoimmune clinical programs, managing cross-functional teams, overseeing external vendors, and operating within regulatory-compliant drug development phases from first-in-human trials through approval. Work setup: not specified, but international and collaborative environment implied.