[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 Description The Senior 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 quality

This 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 assigned

Qualifications

• 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

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