Director, Clinical Operations
4 weeks ago
About Us
Dianthus Therapeutics is a clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency over existing complement therapies. Based in New York City and Waltham, Mass. Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the next generation of antibody complement therapeutics to deliver transformative medicines for patients with severe autoimmune diseases.
Since raising a $100M Series A in April 2022 co-led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company, with participation from additional investors including Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures, and Venrock Healthcare Capital Partners, Dianthus continues tomake progress in advancing its lead monoclonal antibody, DNTH103.
On May 3 rd , 2023, Dianthus announced it entered into a reverse merger transaction with Magenta Therapeutics, a publicly traded biotech company, to create a new public company with the sole focus on advancing Dianthus pipeline of next generation complement therapies. In support of the merger, Dianthus has secured commitments for a $70 million private investment in its common stock and pre-funded warrants from a syndicate of healthcare investors led by Fidelity Management & Research Company, Catalio Capital Management, 5AM Ventures, Avidity Partners, Wedbush Healthcare Partners and founding investors Fairmount, Tellus BioVentures and Venrock Healthcare Capital Partners, that is expected to close immediately prior to completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have approximately $180 million of cash or cash equivalents immediately post-closing.
Dianthus has a steady cadence of milestones with DNTH103 including top line Phase 1 data aiming to confirm potent classical pathway inhibition and favorable, extended PK expected by the end of 2023, initiation of planned Phase 2 trial in generalized Myasthenia Gravis expected in Q1 2024 followed by two additional planned Phase 2 trial initiations in other neuro indications, and planned initiation of an open label proof of efficacy trial in Cold Agglutinin Disease with patient data expected in 2H 2024.
About the Role
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 .
Responsibilities
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.
Experience
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.
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