Associate Director, Clinical Operations

About the Role

The Associate Director, Clinical Operations will be responsible for the oversight, strategic direction and efficient operational planning and implementation of global clinical trials/programs on either a 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 Associate Director, you may also act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus on either a regional or global basis. You will be accountable to ensure all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and be 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 internal and external clinical operations resources while also contributing to strategy, tactics, and driving execution of global clinical studies at a regional or global level
• Influence, oversee and support or lead the planning, budgeting, and study management processes in global clinical studies.
• Leads and supports internal cross functional colleagues to successfully manage external service providers including CRO(s), vendors and subcontractors responsible for conducting global clinical trials to ensure project deliverables are executed on time and within budget at a regional or global level.
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Creates or 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 studies.