Associate Director, Clinical Operations

Responsibilities

• Oversee and direct internal and external clinical operations resources for global clinical studies
• Lead planning, budgeting, and study management processes
• Manage external service providers including CROs, vendors, and subcontractors
• Contribute to the operational design and strategy of clinical trial protocols
• Manage relationships with pharmaceutical partners and suppliers
• Support the development and implementation of department-level SOPs
• Lead or participate in clinical data review and submission activities

Requirements

• 10+ years of experience in the pharmaceutical or medical device industry as a clinical research professional
• Successful project leadership and hands-on managerial experience running clinical trials from inception to completion
• Experience in direct line management or matrix team management
• Demonstrated ability to manage large complex budgets
• Proficiency with EDC, IVR/IWRS, and CTMS systems
• Strong knowledge of international regulatory and ICH GCP guidelines

About the Company

Dianthus Therapeutics develops potentially best-in-class therapies for patients living with severe autoimmune diseases, focusing on antibody-based treatments with improved potency and selectivity.