Manager/Sr Manager Clinical Supply Chain

Role Summary

The Manager / Senior Manager, Clinical Supply Chain is responsible for the ongoing planning and execution of global clinical supply strategies supporting two late-stage, pivotal clinical studies. This role ensures uninterrupted availability of investigational product across multiple regions while maintaining compliance with GMP, GCP, GDP, and inspection-ready standards. The position collaborates with Clinical Operations, Quality, Regulatory Affairs, Manufacturing, and external CDMOs to manage scale, complexity, and regulatory scrutiny typical of Phase III programs.

Responsibilities

• Provide clinical supply operational leadership across multiple global clinical studies.
• Foster cross-functional partnerships to maintain alignment in planning, supply risk management, execution, and compliance.
• Coordinate end-to-end logistics for IP 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 the 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 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; collaborate 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

• 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

• 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 ability 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).