Manager/Sr Manager Clinical Supply Chain

Position Summary• The Manager / Senior Manager, Clinical Supply Chain is responsible for the ongoing planning and execution of • global clinical supply strategies supporting two (2) late-stage, pivotal clinical studies. This role ensures • uninterrupted availability of investigational product (IP) across multiple regions Worldwide while maintaining • compliance with GMP, GCP, GDP, and inspection-ready standards. IP is currently PFS-NSD with a migration path to • PFS-AI (autoinjector). The position partners closely with Clinical Operations, Quality, Regulatory Affairs, • Manufacturing, and external CDMOs to manage increased scale, complexity, and regulatory scrutiny typical of• Phase III programs.

Key Responsibilities• Phase III Clinical Supply Strategy & Planning• Provide clinical supply operational leadership across multiple global clinical studies.• Foster strong cross-functional partnerships to maintain alignment in planning, supply risk management, • execution, and compliance.• Coordinate end-to-end logistics for investigational product expiry, labeling, packaging, and distribution to • depots and clinical sites, including temperature excursion management.• Lead IP label text creation, translation, approval, and printing activities in support of global regulatory • filings, ensuring compliance with local requirements.• Oversee vendors responsible for outsourced clinical supply activities, ensuring deliverables meet scope, • timeline, and quality standards.• Forecast and monitor inventory levels and track/manage domestic and international shipments for timely • delivery.• Coordinate return and destruction of unused or expired investigational product (IP).• Define Interactive Response Technology (IRT) requirements in collaboration with Clinical Operations and • IRT vendor, and lead/document user acceptance testing (UAT) for IRT systems.• Collaborate with stakeholders to develop and maintain the Pharmacy Manual and IP training materials for • clinical site personnel.• Ensure all clinical supply activities are conducted in accordance with SOPs, regulatory standards, and • Quality requirements.• CDMO, Packaging & 3PL Management• Serve as primary clinical supply chain contact for CDMOs, packaging and labeling vendors, and clinical • logistics providers.• Coordinate IP manufacturing campaigns and packaging runs aligned with Phase III timelines.• Monitor vendor performance, capacity, lead times, and risk indicators.• Quality & Inspection Readiness• Ensure all clinical supply chain activities comply with cGMP, GCP, GDP, and global regulatory • requirements.• Partner with Quality on batch release, deviations, investigations, CAPAs, and change controls.• Support regulatory submissions (IND amendments, CTA updates) with supply chain documentation.• Cross-Functional Leadership• Act as a core member of the Phase III study team, providing supply chain leadership and risk mitigation.• Partner with Clinical Operations on enrollment forecasting, country strategy, and site activation plans.• Communicate supply status, risks, and mitigation strategies to senior leadership and governance forums.• Systems, Metrics & Process Optimization• Own and maintain Phase III clinical supply plans, dashboards, and KPIs.• Leverage IRT/RTSM systems and planning tools to support resupply and inventory visibility.• Drive process improvements to improve scalability, compliance, and cost efficiency.

Qualifications/ Experience• Manager: 4–6 years of clinical supply chain experience in biotech or pharma.• Senior Manager: 6–8+ years of progressive clinical supply chain experience.• Direct experience supporting Phase III or late-stage clinical trials.• Experience with global IP distribution, depots, and Country-specific labeling.• Strong background working with CDMOs, Packaging vendors, and Clinical 3PLs.• Experience supporting programs approaching BLA/NDA submission preferred.Skills & Competencies• Deep understanding of Phase III clinical supply models and global distribution strategies.• Strong proficiency in IRT systems, Excel-based forecasting, and planning tools.• Adept with Excel, pivot tables, data analyses and able to interpret large data sets.• Use of Smartsheets to create tables, plans, charts and interactive dashboards.• Strong knowledge of GMP, GCP, GDP, and inspection expectations.• Advanced planning, scenario modeling, and risk management skills.• Ability to manage complexity and ambiguity in late-stage programs.• Excellent cross-functional communication and leadership skills.

Education• Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or related discipline• Advanced degree preferred (Senior Manager level).Leadership Expectations (Senior Manager)• Own clinical supply strategy for one or more Phase III programs.• Mentor and develop clinical supply chain team members.• Influence study and portfolio-level decisions at the Director and VP level.• Lead inspection readiness and supply chain representation during audits.Why Join Us?• We are a great team that is growing!• This is a critical role supporting pivotal trials and regulatory milestones.• Hands-on and high visibility with strategic impact across the organization.• Opportunity to be part of the transition from late-stage clinical to commercial readiness.• We will become the global leader in targeted therapeutics for autoimmune diseases.