Senior Clinical Trial Manager / Associate Director

Role Summary

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 at regional or global level. You will report to the Executive Director, Clinical Development Operations and work with cross-functional teams to accelerate development of clinical assets. As the Senior Manager/Associate Director, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies, including leading the delivery of the ongoing global Phase III CIDP study and providing regional support for planned Phase III studies. You will ensure all activities comply with regulatory guidelines including ICH/GCP and manage internal/external resources to ensure efficient patient recruitment/management, trial site selection/management, trial plan optimization, and overall execution with a focus on quality.

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.
• Lead and support the cross-functional study team to successfully manage external service providers (including CROs, vendors and subcontractors), to ensure project deliverables are executed on time and within budget, while also taking on the clinical trial management (CTM) role as needed.
• Lead/participate in clinical data review.
• Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans.
• Create/support scenario planning and risk-benefit analyses to make recommendations aligned with corporate strategies.
• Contribute to models of performance excellence by identifying best practices, reviewing measurement systems and improving operational efficiency in the department.
• Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery.
• 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

• Experience in the pharmaceutical or biotechnology industry as a clinical research professional, including a 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 the therapeutic area along with willingness to develop in-depth expertise.
• Experience using computer applications including spreadsheets, email, word-processing software, and 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 hinder the effective implementation of the trial and resolve issues in a timely fashion.
• Highly effective verbal and written communication skills with internal and external stakeholders.
• Effectively collaborates with team members.

Education

• Undergraduate degree (Life Sciences preferred) or RN degree, or equivalent. Advanced degree desirable.

Additional Requirements

• Ability to travel (including internationally) and work across cultures.