ClinicalOperationsDevelopmentLead

## Accountabilities Co-lead Clinical Development Teams (CDTs) with Medical Development Leads, ensuring alignment on clinical development strategy and execution of the Clinical Development Plan (CDP). Define, develop, and maintain clinical development strategies across indications, ensuring consistency with the Target Product Profile and overall asset strategy. Oversee end-to-end clinical trial planning and execution, including timelines, budgets, resources, and risk mitigation in collaboration with project management and finance teams. Drive creation and maintenance of the CDP, ensuring endorsement by governance bodies and alignment with strategic objectives and operational feasibility. Lead cross-functional coordination across clinical operations, medical, regulatory, biostatistics, and other stakeholders to ensure integrated execution of clinical programs. Identify, assess, and mitigate program risks, ensuring escalation when needed and driving resolution of complex operational or strategic issues. Oversee vendor and CRO selection and management, ensuring operational quality, compliance, and delivery against expectations. Ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable global regulatory requirements across all clinical activities. Provide oversight of clinical trial design, feasibility, country/site selection, and protocol development in collaboration with global stakeholders. Contribute to governance meetings, program dashboards, and executive reporting on progress, risks, and financial performance. May provide line management for Clinical Trial Managers and Clinical Trial Associates, including hiring, onboarding, performance management, and development. Support continuous improvement initiatives and promote best practices across clinical operations and development functions. Requirements: Bachelor’s or advanced degree in life sciences, medicine, pharmacy, biomedical sciences, or related field; PhD is a plus. 10+ years of experience