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About the Role
The CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and shipping for ongoing ALX Oncology clinical trials. This position plays a critical role in supporting the clinical development pipeline, ensuring that products are available at the right time and place, with the required quality and compliance.
Responsibilities
- Managing, planning, executing, and following up on clinical supply chain transactions and shipping for ongoing ALX Oncology clinical trials.
- Working closely with internal teams, ALX Clinical Operations, and external partners to ensure the seamless flow of Clinical Trial Materials (CTM), including Investigational Products (IP), companion drugs, inventory tracking, and distribution logistics.
- Coordinating domestic and international shipments, including import/export requirements, customs documentation, VAT, and Qualified Person (QP) release activities.
- Managing clinical packaging, labeling, storage, depots, transportation, and logistics through contract manufacturing organizations (CMOs) and other external vendors.
- Collaborating cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, Technical Development, and external partners to ensure timely, compliant execution of clinical supply activities.
- Troubleshooting supply chain issues, proactively identifying risks, and implementing effective solutions.
Requirements
- Experience in clinical trial supply management, including CTM planning, inventory management, forecasting, and global distribution of investigational products (IP).
- Experience coordinating domestic and international shipments, including import/export requirements, customs documentation, VAT, and Qualified Person (QP) release activities.
- Experience managing clinical packaging, labeling, storage, depots, transportation, and logistics through contract manufacturing organizations (CMOs) and other external vendors.
- Experience collaborating cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, Technical Development, and external partners to ensure timely, compliant execution of clinical supply activities.
- Experience troubleshooting supply chain issues, proactively identifying risks, and implementing effective solutions.
- Working knowledge of GMP, GCP, GDP, IRT systems, and global clinical supply chain regulations.
- Experience working independently in an outsourced vendor management environment, managing multiple priorities and external partners within a fast-paced, highly matrixed biotechnology organization.
Skills
- Clinical trial supply management
- CTM planning
- Inventory management
- Forecasting
- Global distribution of investigational products (IP)
- Domestic and international shipments coordination
- Import/export requirements
- Customs documentation
- VAT
- Qualified Person (QP) release activities
- Clinical packaging
- Labeling
- Storage
- Depots
- Transportation
- Logistics
- Contract manufacturing organizations (CMOs) management
- External vendor management
- Cross-functional collaboration
- GMP
- GCP
- GDP
- IRT systems
- Global clinical supply chain regulations
- Independent work
- Managing multiple priorities
Location
- Onsite (preferred for Mondays and Tuesdays)
Work Type
- Contract
- Hybrid
Experience Level
- Contractor
Salary/Compensations
- $50 per hour
About the Company
- ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives.
- ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built.
- Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
- ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.
- A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.
- More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.