Associate Director, Clinical Supply Chain Management

Reporting to the Sr. Director, Clinical Supply Chain, the Associate Director, Clinical Supply Chain Management will provide strategic and operational leadership for end-to-end clinical supply across multiple clinical studies/programs and phases of development. This role is accountable for ensuring reliable supply, proactively identifying and mitigating risk, and driving cross-functional alignment with Clinical Operations, Quality, Regulatory, and external partners. Successful candidates bring a hands-on, solutions-oriented mindset, demonstrate strong judgment and influence, and thrive in a dynamic, fast-paced environment.

This is an office-based role and will based in our office located in Lexington, MA. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day (Friday) remote.

Responsibilities (including, But Not Limited To)

• Provide end-to-end clinical supply leadership to ensure continuous supply of clinical trial material for assigned studies globally
• Ensure on-time startup and ongoing execution of new studies by aligning supply timelines, demand assumptions, and operational readiness with study teams
• Lead selection, oversight, and performance management of clinical packaging, labeling, depots, and distribution vendors; drive KPIs, quality, and continuous improvement
• Oversee planning and execution of packaging and labeling campaigns, including master schedule development and issue resolution across stakeholders
• Provide strategic oversight for comparator sourcing, procurement, labeling, and distribution, including complex global sourcing scenarios
• Review clinical protocols and develop fit-for-purpose clinical supply strategies (including IRT strategy) aligned to program needs, timelines, and budget
• Partner cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, CMC/Manufacturing, and Finance to ensure alignment, compliance, and timely decision-making
• Translate protocols and study assumptions into demand forecasts across scenarios; communicate risks, constraints, and recommendations to stakeholders
• Oversee clinical labeling strategy and execution (label design, translation oversight, production, change control) ensuring country and regulatory requirements are met
• Develop and maintain integrated supply plans to support forecasts, including overage strategy, inventory governance, and regular updates to project teams and leadership
• Lead global distribution and logistics strategy for clinical programs, including import/export execution, temperature-controlled shipments, and oversight of 3PL/regional depot networks
• Lead packaging/distribution scope and vendor governance, including contract negotiations, supply plan design, and development/approval of distribution instructions and operational playbooks
• Own risk management for clinical supply (e.g., demand, lead times, quality, distribution), drive mitigation plans, and escalate critical issues with clear options and recommendations
• Provide functional oversight for Interactive Response Technology (IRT) configuration and testing (specification development, UAT coordination, go-live readiness) in partnership with Clinical Operations and vendors
• Oversee study closeout activities including drug reconciliation, returns/destruction strategy, and final inventory disposition in compliance with applicable requirements
• Ensure clinical supply deliverables and documentation are inspection-ready and appropriately filed in the eTMF in alignment with Quality standards
• Develop, manage, and forecast clinical supply budgets for assigned studies/programs; track spend, purchase orders, and accruals; provide financial transparency to stakeholders
• Establish and monitor clinical supply timelines and key milestones; drive issue management, governance, and executive-ready communication for on-time delivery
  
  

Qualifications

• BS/BA degree required (advanced degree a plus) with 6 years of progressive experience in Clinical Supply Chain within a biotechnology or pharmaceutical environment, including multi-study/program ownership
• Demonstrated experience leading contract packaging and labeling organizations, including governance, performance management, and issue escalation
• Proven ability to develop and implement risk-based supply strategies across early- to late-stage clinical development programs, including scenario planning and trade-off decision support
• Strong understanding of global regulatory expectations for clinical supply distribution across US, EU, and APAC, including testing, labeling, and import/export requirements
• Deep knowledge of cGMP, GCP, GDP, and transportation requirements for pharmaceutical materials; experience supporting inspection readiness and deviation/CAPA investigations as applicable
• Extensive global distribution experience, including regional depot strategy and operational execution; familiarity partnering with QP release processes and IRT providers
• Strong project/program management skills with demonstrated ability to lead cross-functional teams, influence without authority, and communicate effectively to senior stakeholders
• Thrives in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient; demonstrated ability to develop scalable processes and mentor/train others
  
  

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.