Sr. Director, Clinical Supply Chain Management and Systems

About the role

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most. The Senior Director, Clinical Supply Chain Management and Systems will be responsible for executing and refining organizational strategies for Kiniksa’s clinical supply team. This role will lead and mentor a team of Clinical Supply Managers to ensure that processes are followed and improved, and that all clinical trials have a continuous supply of Clinical Trial Materials (CTM). This role will also own the key clinical supply systems including IRT and will be responsible for partnering with Clinical and CSV QA to ensure process efficiency in the selection, design and testing of these systems. This role will partner with internal and external groups to develop and accomplish all the tasks required to support a continuous supply of CTM. The individual will need to be highly engaged in: Forecasting and Planning, Packaging and Labeling, Global Distribution, Comparator procurement, IRT Technology, Outsourcing Management, Project Management, and Conformance of Quality and Compliance requirements. Successful candidates will possess a fun, flexible, roll up your sleeves attitude, have the ability to work independently and enjoy working in a dynamic, fast-paced environment during a period of significant growth. The position will report to the VP, Supply Chain. This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities

• Lead and mentor a team of clinical supply managers to ensure that each trial has on time, compliant, continuous supply of material and while ensuring:
  • CTM supply plans (packaging, labeling and distribution) and timelines integrate with clinical trial requirements, complex distribution requirements (import/export) and maximize supply efficiency and minimize waste
  • On time development and approval of global labels to support regulatory submissions and global supply
  • Inspection readiness and ensuring all documents are filed within the eTMF
• Lead and manage the IRT build cross-functionally for Kiniksa, partnering with Clinical Operations, Data Management and Biostats along with other applicable functional areas, this includes:
  • Capturing the protocol requirements
  • Leading the User Requirements Specification with the vendor and functional areas
  • Authoring UAT scripts, leading UAT testing
  • Man