[Hiring] Senior Clinical Trial Manager / Associate Director @Dianthus Therapeutics

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role DescriptionTheSenior Clinical Trial Manager/Associate Director will be responsible for the oversight, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional or global level. • Report to the Executive Director, Clinical Development Operations• Work with cross-functional team management to accelerate development of clinical assets• Act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies• Lead the delivery of the ongoing global Phase III CIDP study and provide regional support for the planned Phase III study• Ensure all activities occur in compliance with appropriate regulations and guidelines including ICH/GCP• Oversee and manage internal and external resources for efficient patient recruitment/management, trial site selection/management, trial plan optimization and overall execution with a focus on qualityThis is a unique opportunity to positively impact lives as part of a team driven by continuous innovation with very high scientific integrity.Key Responsibilities• Manage and support relevant internal and external clinical operations resources while contributing to strategy, tactics, and execution of global clinical studies• Influence, manage and lead the planning, budgeting, and study management processes in global clinical studies• Accountable for oversight and management of CRO/vendor partners contracted to the study/region assigned• Lead and support the cross-functional study team to manage external service providers' functional counterparts• Lead/participate in clinical data review• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study plans• Create/support scenario planning and risk-benefit analyses to align with corporate strategies• Identify best practices, review measurement systems and improve operational efficiency in the department• Manage relationships with vendor partners and suppliers in clinical programs• Ensure efficient and effective communication and exchange of information across projects and reporting functions• May participate in Clinical submission activities• Support the development and implementation of department level SOPs for clinical trials and related activities• Interface with departments within and outside of Dianthus including Finance, Regulatory, Quality, and Tech Ops• Represent the company at Investigator Meetings• Other duties as may be determined or assignedQualifications• Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent; advanced degree desirable• Experience in the pharmaceutical or biotechnology industry as a clinical research professional• Successful clinical trial management role and hands-on managerial experience executing high-quality clinical trials from inception to completion• Excellent knowledge of international regulatory and ICH GCP guidelines• Experience in clinical trial management and managing high-functioning clinical trial project teams• Demonstrated ability to manage large complex budgets• Experience and understanding of the drug development process, clinical development planning and clinical trial execution• Understanding of clinical aspects of therapeutic area along with willingness to develop in-depth expertise• Experience using computer applications including spreadsheets, email, word-processing software & web-based systems (EDC, IVR/IWRS, CTMS)• Ability to work well independently as well as a member of multiple, integrated teams• Ability to contribute creative yet practical solutions to problems• Ability to multi-task and manage several projects in parallel while paying attention to detail• Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial• Highly effective verbal and written communication skills with internal and external stakeholders• Effectively collaborates with team members• Ability to travel (including internationally) and work across cultures Apply tot his job