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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 role ensures the seamless flow of Clinical Trial Materials (CTM), including Investigational Products (IP), companion drugs, inventory tracking, and distribution logistics, playing a critical role in supporting the clinical development pipeline.

Responsibilities

Managing, planning, executing, and following up on clinical supply chain transactions and shipping for ongoing ALX Oncology clinical trials.
Ensuring 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.
Working independently in an outsourced vendor management environment, managing multiple priorities and external partners within a fast-paced, highly matrixed biotechnology organization.

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.
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)
Coordinating domestic and international shipments
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
Supply chain issue troubleshooting
Risk identification
Solution implementation
GMP
GCP
GDP
IRT systems
Global clinical supply chain regulations

Location

Onsite

Work Type

Contract
Hybrid

Experience Level

6 to 12-month contract assignment

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.