Senior Director, Clinical Operations

About Us

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 of Clinical Operations, you will demonstrate effective leadership and cross-functional team management that accelerates development of assets, in support of Dianthus Myasthenia Gravis studies and future studies as assigned. You may also act as Clinical Project Manager (CPM) responsible for implementation, execution and 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.

Responsibilities

• Oversee and direct relevant clinical operations resources while also contributing to strategy, tactics, and driving execution of one or more global clinical programs,
• Influence, oversee and lead the planning, budgeting, and study management processes in global clinical studies,
• Responsible for support of studies at a regional and global level, depending on study needs.
• Manage and lead other clinical operations team members 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.
• 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 if applicable.
• Supports the development and implementation of department level SOPs for clinical trials and related activities.
• Interface with departments within and outside of Clinical Operations including Clinical Development, Safety, Finance, Clinical Supplies, Regulatory Affairs, Legal Affairs, and Business Development and any other departments as needed.
• 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.

  • 10-15 years of experience in the pharmaceutical or medical device industry as a clinical research professional, including successful project leadership role and hands-on managerial experience running high quality clinical trials from inception to completion.
  • Excellent knowledge of international regulatory and ICH GCP guidelines.
  • Experience in direct line management preferred and hands-on experience in monitoring and managing high-functioning clinical trial project teams.
  • Demonstrated success in coordinating external resources for clinical development and in working with pharmaceutical partners.
  • 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.
  • Prior 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. A wide degree of creativity and latitude is expected.
  • Ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion.
  • 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.