Senior Director, 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 Director, Clinical Supply chain, you will lead, execute and oversee the clinical supply chain efforts across all programs, while also playing a critical role in shaping the future supply chain strategy to ensure readiness for late stage and commercialization activities.

Reporting to the VP, Technical Operations, you will be a hands-on player coach, leading a team of two clinical supply chain professionals and also serve as the clinical supply lead for one of our Phase 2 programs. Day to day you will work with cross-functional program teams, ensure successful labeling and delivery of investigational products and ancillary supplies to our global sites, and develop strategic long-term plans for future programs, pivotal trials and eventual commercialization efforts. You must have experience with full life cycle of clinical supply through commercialization and willingness to remain a hands-on contributor to effectively support our programs and future pipeline.

This is a great opportunity to join a growing clinical stage biotech company and have significant impact on the long-term success of the organization. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.

Key Responsibilities

• Perform demand forecasting, determination of an appropriate presentation to the clinical site and subject, setting production schedules, inventory management at depots and sites, order management and proof of delivery, return or destruction and global distribution logistics including import and export management.
• Create global supply strategies, supply plans to support clinical studies.
• Build effective partnerships with key stakeholders across a range of functions, including CMC manufacturing, Quality Assurance, Clinical Operations, and external service providers (primarily CMOs, 3PLs, CROs, freight vendors) to ensure delivery of our drug product to clinical trial sites.
• Develop and implement risk mitigation strategies, contingency plans, and business continuity measures to ensure uninterrupted supply chain operations.
• Prepare Supply Chain analysis' and Executive-level presentations for decision making purposes.
• Drive continuous improvement initiatives to enhance the efficiency, flexibility, and scalability of the clinical supply chain operation.
• Manage clinical labeling including label design, translation and production.
• Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies.
• Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors.
• Prepare, forecast and manage the budget and ensure department adhere to the approved budget.
• Develop team and provide coaching to support their individual growth.
  
  

Experience

• B.S. or M.S. in scientific fields with experience in the pharmaceutical or biotechnology clinical supply chain and logistics.
• Strong experience managing supply chain activities for US and global clinical trials including managing and overseeing packaging, labeling and distribution centers.
• Strong knowledge and experience in clinical IRT systems.
• Strong experience in demand and supply planning; Familiarity with sales and operations planning processes and data requirements.
• Working knowledge of import and export laws and processes.
• Working knowledge and experience in cold chain freight management; specific experience in biologics strongly preferred.
• Working knowledge / experience of the pharmaceutical drug products in terms of manufacturing and design a plus.
• Working knowledge of drug development process (Phase I-IV).
• Working knowledge of cGMPs and familiar with US regulations.
• Ability to act as an effective leader in a virtual matrix environment across multiple teams and geographies.
• Experience with clinical labeling, packaging and distribution including cold chain, importing and exporting logistics.