CMC Planner, Supply Chain (Contract)

ALX Oncology Inc.

$104K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Experience in clinical trial supply management, including planning and forecasting for clinical trial materials.
  • Knowledge of domestic and international shipment coordination, including customs and import/export regulations.
  • Ability to manage packaging, labeling, and logistics with external vendors effectively.
  • Capability to collaborate with multiple internal teams and external partners for clinical supply activities.
  • Strong troubleshooting skills, with a focus on proactive risk identification and resolution.
  • Familiarity with industry regulations, including GMP, GCP, and GDP, as well as IRT systems.
  • Proven experience managing priorities in a fast-paced, matrixed biotechnology environment.

Responsibilities

  • Manage and execute clinical supply chain transactions for ALX Oncology clinical trials.
  • Ensure timely availability of Clinical Trial Materials (CTM) throughout the supply chain.
  • Coordinate shipping logistics and compliance with regulations and quality standards.
  • Collaborate cross-functionally with Clinical Operations and other teams to streamline processes.
  • Identify and resolve supply chain issues effectively to maintain uninterrupted trial progress.
  • Oversee inventory tracking and distribution logistics for investigational products.
  • Facilitate communication between internal teams and external partners for seamless operations.

Benefits

  • Opportunity to work with a leading biotechnology company focused on oncology.
  • Gain hands-on experience in a critical role within clinical trials.
  • Experience a supportive hybrid work environment with onsite collaboration.
  • Potential for contract extension based on performance and project needs.
Full Job Description
Reporting to the Manager, Clinical Supply Chain, the contract CMC Planner, Supply Chain is responsible for managing, planning, executing, and following up on clinical supply chain transactions and shipping for ongoing ALX Oncology (ALX) clinical trials. The CMC Planner will work 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. 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.

This is a six-month contract assignment expected to require 40 hours per week. The anticipated pay rate is approximately $50 per hour. Candidates who can work onsite on Mondays and Tuesdays as part of the company's hybrid work model will be given preference.

Qualified contractors should have experience that includes:

  • Clinical trial supply management, including CTM planning, inventory management, forecasting, and global distribution of investigational products (IP).
  • 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 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.


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