Senior Clinical Trial Manager / Associate Director

Senior Clinical Trial Manager / Associate Director

Remote

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.

About the Role

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.

You will report to the Executive Director, Clinical Development Operations and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager / Associate Director, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus.

This is a unique opportunity where you have a chance to positively impact lives as part of the team driven by continuous innovation with very high scientific integrity. We are building a team who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.

Key Responsibilities

• Manage and support relevant internal and external clinical operations resources while also contributing to strategy, tactics, and driving 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
• Leads and supports the cross functional study team to successfully manage external service providers functional counterparts.
• Leads / participates in clinical data review
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates / supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies.
• Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in department.
• Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across projects and reporting functions.
• May participate in Clinical submission activities.
• Supports 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 such duties as may be determined or assigned.

Experience

Dianthus Therapeutics is an Equal Opportunity Employer.

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