Reporting to the Manager, Clinical Supply Chain, the CMC Planner 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.
Preference will be given to applicants who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model. Applicants must be authorized to work in the United States without current or future employer sponsorship (e.g., H-1B sponsorship).
Key Responsibilities Include: - 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.
Preferred Qualifications Include: - Bachelor's degree in supply chain management, Life Sciences, Biotechnology, Business, or a related field. A master's degree or relevant professional certification (e.g., APICS, CSCP) is a plus.
- 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.
CompensationThe salary range for this position at our South San Francisco, CA corporate office is $100,000 - $110,000. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/
Information for Recruitment AgenciesPlease note that 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.
