layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Manager, Clinical Supply Chain Management at Kiniksa Pharmaceuticals | LAYIQ

(including, but not limited to): Provide end-to-end clinical supply support 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
Support comparator sourcing, procurement, labeling, and distribution strategies, including coordination of complex global sourcing scenarios
Review clinical protocols and develop fit-for-purpose clinical supply plans, including IRT considerations, aligned to study 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
Manage global distribution and logistics activities for assigned clinical studies, including import/export coordination, temperature-controlled shipments, and oversight of 3PL/regional depot partners
Manage packaging/distribution scope and vendor coordination, including support for contracts, 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
Support Interactive Response Technology (IRT) configuration and testing activities, including specification review, UAT coordination, and 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
Stand-Out Skills for Impact: Strategic clinical supply planning mindset with the ability to translate protocol design, enrollment assumptions, manufacturing constraints, and country requirements into practical, risk-based supply strategies
Strong analytical capability to manage forecasts, inventory signals, resupply triggers, expiry exposure, and scenario planning across global studies
Demonstrated vendor management across packaging, labeling, depots, logistics providers, CMOs/CPOs, CROs, and IRT partners, including clear expectations, escalation pathways, and performance accountability
Operational agility and sound judgment to anticipate supply disruptions, evaluate trade-offs, and drive timely decisions in a fast-paced clinical development environment
Clear, executive-ready communication style with the ability to influence cross-functional stakeholders and communicate risks, options, and recommendations with confidence

BS/BA degree required (advanced degree a plus) with 4+ years of progressive experience in Clinical Supply Chain within a biotechnology or pharmaceutical environment, including study-level ownership
Demonstrated experience leading contract packaging and labeling organizations, including governance, performance management, and issue escalation
Proven ability to develop and execute risk-based supply plans across early- to late-stage clinical development studies, 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 management skills with demonstrated ability to coordinate cross-functional teams, influence without authority, and communicate effectively with internal and external stakeholders
Thrives in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient; demonstrated ability to support scalable processes and train others
Experience using IRT/IXRS, inventory tracking tools, vendor portals, ERP modules, Smartsheet, Excel, or similar systems to manage clinical supply inventory, shipments, forecasts, and documentation
Demonstrated ability to manage temperature-controlled clinical supply operations, including excursion review, documentation, mitigation planning, and coordination with Quality and logistics partners
Experience supporting clinical supply documentation such as label text, packaging records, distribution instructions, shipping documentation, inventory reconciliations, and study closeout records
Ability to balance patient supply continuity, cost discipline, expiry/scrap risk, and operational feasibility when developing clinical supply recommendations
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Senior Manager, Clinical Supply Chain Management

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Responsibilities

Qualifications:

Equal opportunity and accommodations

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