Sr. Director, Clinical Supply Chain Management and Systems

Job description

Sr. Director, Clinical Supply Chain Management and Systems

Lexington, MA

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 (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

StandoutSkills forImpact:

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

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$264,000 - $271,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

#J-18808-Ljbffr

Worksite address

lexington, MA, 02173, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.