Kiniksapharmaceuticals

Kiniksapharmaceuticals

Assoc. Director, Clinical Supply Chain Management

Lexington, MA · Director

Sponsorship not specified$160k-$181kDetected 35 days ago
GCPForecastingSupply ChainLogisticsProcurementPerformance ManagementClinical TrialsGMPFDA RegulatoryLeadershipCommunicationDemand PlanningRegulatory Affairs

About the role

  • 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.
  • 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.

Responsibilities

  • Lead selection, oversight, and performance management of clinical packaging, labeling, depots, and distribution vendors; drive KPIs, quality, and continuous improvement
  • 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
  • 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
  • Oversee clinical labeling strategy and execution (label design, translation oversight, production, change control) ensuring country and regulatory requirements are met
  • 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

Requirements

  • 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
  • familiarity partnering with QP release processes and IRT providers

Nice to have

  • 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

Compensation

  • $160,000 - $181,000 USD
  • 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.

Benefits

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

Company info

  • 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.
  • Reporting to the Sr.
  • 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.
  • Stand Out Skills for Impact:

Equal opportunity

  • Please contact us to request accommodation.
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