Job description
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 Clinical Trial Manager will be responsible for the oversight, operational direction and efficient operational planning and implementation of Dianthus clinical trials on either regional level.
You will report to the APAC Clinical Operations lead and work with cross-functional team management to accelerate development of clinical assets. As the Sr Manager, you will act as Clinical Project Manager (CPM) responsible for implementation, execution and overall resource management of clinical studies being conducted by Dianthus, in particular in leading the delivery of our ongoing global Phase II/III studies and APAC regional support. 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/management, trial site selection/management, trial plan optimization and overall execution with a focus on quality. You must be fluent in English and Mandarin to be successful in this role.
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 (including CRO(s), vendors and subcontractors), to ensure project deliverables are executed on time and within budget, whilst also taking on clinical trial management (CTM) role as needed.
- 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
- 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, including 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 therapeutic area along with willingness to develop in-depth expertise.
- 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.
