Associate Director, Clinical Supply Chain Management
$160,000–$181,000 year
Hybrid · Lexington, Massachusetts, United States
Job Summary
Associate Director, Clinical Supply Chain Management provides end-to-end clinical supply leadership for global studies, ensuring reliable supply, on-time startup and execution, and risk mitigation. Leads packaging/labeling vendors, master scheduling, and distribution planning; oversees comparator sourcing, labeling, and distribution strategies; translates protocols into demand forecasts; aligns cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, CMC/Manufacturing, and Finance; ensures regulatory and country-specific labeling requirements, inventory governance, and inspection readiness; manages budgets and milestones, and oversees IRT configuration/testing with vendors.
Required Qualifications
- BS/BA degree required
- 6+ years of progressive experience in Clinical Supply Chain within a biotechnology or pharmaceutical environment, including multi-study/program ownership
- 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, proactive environment; ability to develop scalable processes and mentor/train others
- The expected salary range for the Associate Director, Clinical Supply Chain Management position is $160,000 - $181,000 annually
- Kiniksa is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status
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