Assoc. Director, Clinical Supply Chain Management

Kiniksa Pharmaceuticals • Lexington, MA

7d • $160,000 - $181,000 • Onsite

About The Position

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.
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 role is based in our Lexington, MA office and requires employees to be onsite five days per week.

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

Nice To Haves

• End-to-End Clinical Supply Leadership: Drive seamless global supply across multi-phase trials, ensuring uninterrupted drug availability through strategic planning, demand forecasting, and integrated supply execution
• Risk Mitigation & Strategic Decision-Making: Anticipate supply chain risks, develop scenario-based strategies, and deliver clear, data-driven recommendations to maintain timelines, budget, and compliance
• Vendor & Global Distribution Excellence: Lead selection and oversight of packaging, labeling, and logistics partners; optimize 3PL/depot networks and drive KPIs, quality, and continuous improvement
• Cross-Functional Influence & Execution: Partner with Clinical Ops, QA, Regulatory, CMC, and external stakeholders to align on study timelines, IRT strategy, and operational readiness in fast-paced environments.

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager