Sr. Director, Clinical Supply Chain Management and Systems

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 (including, but not limited to):  

• 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
• Managing changes through the system to ensure correct functionality is maintained.
• Lead the clinical supply system development and implementation including but not limited to:
• Forecasting
• Inventory management
• Assess and identify new vendors that can support
• Identify new systems and technologies to drive efficiency within the clinical supply organization
• Develop and manage clinical supply budget.  Manage contracts, purchase orders and ensure invoices are reviewed and approved in a timely manner. Work closely with finance and suppliers as need to reconcile issues as appropriate
• Work closely with CMC/Tech Ops, Quality, Regulatory and other internal departments
• Identify gaps in departmental procedures. Create, update, and implement best practices and SOPs to close those gaps
• Lead initiatives for generation, refinement and maintenance of clinical supply infrastructure, systems and cross-functional collaboration
• Ensure department compliance with SOPs and regulatory guidelines to ensure that the department is always inspection ready

Standout Skills for Impact: 

• Strategic clinical supply leadership – able to translate clinical development priorities into practical, risk-based supply strategies that ensure continuous patient supply
• IRT development experience – experience of leading IRT systems development cross-functionally throughout the trial lifecycle
• Inspection readiness and compliance leadership — maintains a strong quality mindset across GMP/GCP/GDP requirements, eTMF documentation, vendor oversight, and audit readiness.
• Team development and mentoring — builds capability in Clinical Supply Managers through coaching, accountability, prioritisation, and clear ways of working.
• Vendor and outsourcing management — manages external partners effectively, balancing timelines, quality, budget, performance, and issue resolution.
• Hands-on execution with senior-level judgement — combines strategic thinking with a “roll up your sleeves” approach to solve problems quickly in a fast-paced environment.

Qualifications and Experience:  

• Requires a BS/BA degree with at least 15+ years’ experience years’ experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment or relevant discipline
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
• Experience with selection/implementation and management of IRT systems, label design, labeling and packaging operations, distribution, and supply chain CMO
• Experience with developing risk-based supply strategy for early to late stage clinical development programs
• Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
• Global distribution experience including working with QP, IXRS and regional depots.
• Excellent project management and communication skills
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient
• Desire to make significant contributions to process improvements and tactical execution of day-to-day activities