Associate Director, Clinical Supply Chain Management

Kiniksa Pharmaceuticals•Lexington, MA

6h•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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