Senior Manager, Clinical Supply Chain

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

As the Senior Manager, Clinical Supply Chain, you will have a direct impact on our clinical drug supply chain for a key program in Phase II/III clinical trials.

Reporting to the Senior Director, Supply Chain, you will build effective partnerships with key stakeholders across a range of functions, including CMC manufacturing, Quality Assurance, Clinical Operations, and external service providers (primarily CDMOs, 3PLs, and CROs) to ensure delivery of our drug product to clinical trial sites. You will manage end-to-end supply needs by planning global clinical trial supply requirements and managing imports / exports and logistics. Prior experience overseeing a global clinical supply chain (EU, LATAM, APAC, etc.) is essential to be successful in this role. A background in clinical demand planning, logistics, and product commercialization and distribution is highly preferred.

This is an exciting opportunity to make significant contributions to the evolution of Dianthus’s global supply chain strategy to support our clinical development program(s) and beyond. We are building a team that holds our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.

Key Responsibilities

• Clinical Supply Planning: Develop and execute comprehensive clinical supply plans, including demand forecasting, inventory management, and allocation strategies to support ongoing and upcoming clinical trials.
• Logistics Management: Manage all aspects of clinical trial material logistics, including vendor selection and management, transportation, cold chain management, and ensuring compliance with global import / export requirements.
• Inventory Control: Implement robust inventory control practices to optimize the use of investigational products, reduce waste, and ensure timely resupply.
• Distribution Oversight: Oversee the distribution of investigational products to clinical trial sites, ensuring on-time delivery and compliance with regulatory requirements.
• Risk Mitigation: Identify potential risks and develop contingency plans to mitigate supply chain disruptions, ensuring uninterrupted support for clinical trials.
• Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Quality Assurance, and Contract Manufacturing, to align supply chain activities with trial timelines and regulatory requirements.
• Compliance and Documentation: Ensure compliance with Good Clinical Practices (GCP), Good Distribution Practices (GDP), and other relevant regulations. Maintain accurate and comprehensive documentation.
• Budget Management: Assist in development of clinical supply chain budget; manage budget of assigned trials, including cost forecasting, tracking, and optimization.
• Continuous Improvement: Continuously evaluate and improve supply chain processes, identifying opportunities for efficiency gains and cost savings.

Experience

• Experience in clinical supply chain management, with a strong background in planning and logistics within the pharmaceutical / biotechnology industry.
• Strong knowledge of clinical trial operations, global regulations, and compliance requirements (GCP, GDP, ICH, etc.).
• Knowledge in global trade compliance and pharmaceutical import / export requirements.
• Experience with clinical supply planning and inventory management software (IRT systems).
• Proven leadership skills with the ability to manage and develop a team.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Demonstrated ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
• Certification in Supply Chain Management or Logistics (e.g. APICS, CSCMP) is a plus.