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About the Role
The CMC Planner 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) and plays a critical role in supporting the clinical development pipeline.
Responsibilities
- Coordinate clinical trial material (CTM) shipment orders in accordance with supply plans and requests from the ALX Clinical Operations team to ensure timely and compliant delivery to investigator sites.
- Coordinate international CTM shipments, including customs documentation, Value Added Tax (VAT) requirements, and related reporting, and work with Qualified Persons (QPs) and ALX Quality Assurance (QA) to support release of CTM for clinical use.
- Process manual shipments to clinical sites, investigator-sponsored trials (ISTs), and contract/service provider organizations.
- Provide oversight of contract manufacturing organizations (CMOs) and other vendors supporting labeling and packaging, depot services, storage, and transportation logistics.
- Communicate clinical packaging plans to contract packaging sites and coordinate packaging activities to support clinical supply requirements.
- Support the development and execution of timelines for CTM manufacturing, labeling, packaging, release, distribution, return, and destruction.
- Troubleshoot and coordinate resolution of investigational product (IP) shipment issues.
- Assess, coordinate, and track the purchase, distribution, and labeling of comparator and companion products and other ancillary clinical trial materials.
- Manage and track IP inventory, identify potential supply shortages, and provide recommendations for resupply based on usage trends and forecasts.
- Maintain accurate clinical supply inventory records using appropriate inventory management and reporting tools.
- Review and provide input and approval for user requirements specifications associated with Interactive Response Technology (IRT) systems.
- Collaborate with Clinical Operations, CMOs, QA, and Regulatory Affairs to develop compliant labels for finished IP, including label text, proofs, and country-specific translations.
- Participate in project team meetings and collaborate cross-functionally with Technical Development, Clinical Operations, Regulatory Affairs, and QA to communicate clinical supply status, risks, and issues.
- Contribute to a culture that reflects ALX's values by acting with integrity, accountability, transparency, and respect. Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.
- Support other CMC, Supply Chain, and organizational priorities as needed.
Requirements
- Bachelor’s degree in supply chain management, Life Sciences, Biotechnology, Business, or a related field.
- Approximately 2 years of related experience in clinical supply management within the pharmaceutical or biopharmaceutical industry.
- Experience with clinical trial supply management, including labeling, packaging, and distribution of investigational product (IP).
- Experience with supply chain and distribution logistics, including import/export, VAT, and customs requirements.
- Experience working in an outsourced vendor management environment and effectively managing external partners.
- General knowledge of applicable GMP, GCP, and GDP regulations related to investigational product.
- Strong analytical and organizational skills, with excellent attention to detail and the ability to maintain accurate and timely documentation.
- Strong written, verbal, and interpersonal communication skills, with the ability to collaborate effectively with internal and external stakeholders.
- Ability to prioritize and manage multiple responsibilities, adapt to changing business needs, and address routine issues with appropriate guidance while recognizing when to seek input or escalate concerns.
- Proficiency with common business applications, including Word, Excel, PowerPoint, and Project.
- Must be authorized to work in the United States without current or future employer sponsorship.
Skills
- Supply Chain Management
- Clinical Supply Management
- Labeling
- Packaging
- Distribution Logistics
- Import/Export
- VAT
- Customs Requirements
- Vendor Management
- GMP
- GCP
- GDP
- Analytical Skills
- Organizational Skills
- Attention to Detail
- Documentation
- Written Communication
- Verbal Communication
- Interpersonal Communication
- Collaboration
- Prioritization
- Adaptability
- Problem Solving
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Project
- Interactive Response Technology (IRT) systems
Location
- South San Francisco, CA
Work Type
- Hybrid
Experience Level
- Approximately 2 years of related experience
Education Level
- Bachelor's degree in supply chain management, Life Sciences, Biotechnology, Business, or a related field.
- Master's degree or relevant professional certification (e.g., APICS, CSCP) is a plus.
Salary/Compensations
- $100,000 - $110,000
Benefits
- Stock programs
- Performance-based bonus
- Comprehensive benefits package including 401K
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.
Equal Opportunity
- ALX Oncology does not accept unsolicited resumes or candidate information from recruitment agencies, including blinded or anonymized resumes, and will not be responsible for any fees associated with unsolicited submissions.
- Do not contact hiring managers or other ALX Oncology employees directly.
- Recruiting activities are managed through our Human Resources team.