Strategic Director, Global Clinical Supply & Systems

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 264,000 - 271,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking a Senior Director of Clinical Supply Chain Management and Systems to lead a team ensuring continuous CTM supply across clinical trials. The role focuses on IRT systems, labeling, packaging, distribution, and vendor management in a fast-paced environment.

Based in Lexington, MA, this onsite position reports to the VP of Supply Chain and emphasizes regulatory readiness, budgeting, and cross-functional collaboration with Clinical, QA, and Finance teams.

Qualifications

• Strategic clinical supply leadership translating development priorities into supply strategies.
• Experience leading cross-functional IRT systems development.
• Knowledge of GMP/GCP/GDP and regulatory requirements for global distribution.

Responsibilities

• Lead and mentor clinical supply managers for on-time, compliant CTM supply.
• Oversee CTM packing, labeling, and distribution plans across trials.
• Develop and approve global labels to support regulatory submissions and supply.
• Own IRT build and testing with vendors and functional areas.
• Develop and manage the clinical supply budget and contracting.
• Ensure SOPs/regulatory readiness and audit preparedness.

Skills

Strategic leadership

IRT development

Inspection readiness

Team development

Vendor management

Hands-on execution

Education

BS/BA degree

Tools

IRT systems

Job description

Kiniksa Pharmaceuticals is seeking a Senior Director of Clinical Supply Chain Management and Systems to lead a team ensuring continuous CTM supply across clinical trials. The role focuses on IRT systems, labeling, packaging, distribution, and vendor management in a fast-paced environment.

Based in Lexington, MA, this onsite position reports to the VP of Supply Chain and emphasizes regulatory readiness, budgeting, and cross-functional collaboration with Clinical, QA, and Finance teams.