Senior Director, Clinical Operations

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. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

The Senior Director, Clinical Operations is responsible for the oversight, strategic direction and efficient operational planning and implementation of global clinical trials/programs.

Reporting to the Executive Director, Clinical Operations, you will ensure effective leadership and cross-functional team management that accelerates global development of assets. You may also act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and is responsible to oversee and manage internal and external resources to ensure efficient patient recruitment, trial site selection, trial plan optimization and execution of trials with a focus on quality.

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 culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Oversee and direct relevant clinical operations resources while also contributing to strategy, tactics, and driving execution of multiple global clinical programs.
• Influence, oversee and lead the planning, budgeting, and study management processes in global clinical studies.
• Leads direct reports to successfully manage external service providers including CRO(s), vendors and subcontractors, in addition to internal cross functional colleagues responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget.
• 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.
• Review, assess and manage resource strategies with internal and external groups for global drug development programs, working strategically with suppliers/CROs.
• Manage relationships with pharmaceutical partners and suppliers in clinical programs to optimize delivery.
• Ensures efficient and effective communication and exchange of information across projects and reporting functions.
• Leads/participates in clinical data review.
• Participates in Clinical submission activities.
• May serve as the clinical operations representative at regulatory agency meetings.
• As needed, participates in due diligence activities for in-licensing opportunities.
• Develop training plans, act as mentor and conduct performance reviews for all direct reports.
• Supports the development and implementation of department level SOPs for clinical trials and related activities.
• Interface with departments within and outside of Clinical, including Finance, Regulatory Affairs, Legal Affairs, and Business Development.
• Represent the company at Investigator Meetings.
• Other such duties as may be determined or assigned.

Experience

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable.
• Experience in the pharmaceutical or biotechnology industry as a clinical research professional, incl