Director, Clinical Operations

February 23

Dianthus Therapeutics, Inc.

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Unlocking the full potential of complement therapeutics through the power of selectivity.

2 - 10

💰 $100M Private Equity Round on 2022-04

Description

• Oversee and direct relevant internal and external 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, whilst also taking on clinical trial management (CTM) role as needed. • 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. • As needed, supports due diligence activities for in-licensing opportunities. • Develop training plans, act as mentor and conduct performance reviews for all direct reports, as applicable. • 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.

Requirements

• Requires a minimum of Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent. Advanced degree desirable. • Experience in the pharmaceutical or medical device 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 direct line management and hands-on experience in monitoring and managing high-functioning clinical trial project teams is an asset. • 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. • 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.

Benefits

• Competitive salary and benefit package • Opportunity to work with experienced team of biotech and pharma executives • Opportunity to develop next-generation antibody complement therapeutics to deliver transformative medicines for patients with severe autoimmune diseases