JOB POSTING

Clinical Supply Manager

ALX Oncology Inc. (ALX) is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX is advancing novel therapeutics, targeted for intravenous delivery, from preclinical development to late-stage clinical trials and commercialization.  

ALX is seeking a highly motivated and talented individual to lead and manage investigational product (IP) supply operations for multiple clinical trials, manage the packaging and labeling process, and forecast clinical demand. This impactful full-time position will report to the Vice President of Chemistry, Manufacturing, and Controls.

The Clinical Supply Manager is responsible for the forecasting, management, planning, packaging, labeling, and distribution of investigational products and clinical trial materials to support the Company’s clinical studies ranging from Phase I to Phase III, along with Investigator Sponsored Trials and potential Compassionate Use situations. The core responsibilities include on-time delivery of study drug to patients and management of the clinical supply chain, i.e., packaging, labeling, distribution, inventory management, returns, and destruction of Clinical Trial Material.

Responsibilities

  • Ensure on-time delivery of clinical IP supply (ALX148, placebo, companion drug, comparator drug, and commercial drug) to depots and clinical sites in accordance with each clinical protocol and plan. 
  • Oversee IP shipment orders according to supply plans, or as requested by the Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites.
  • Oversee international shipments requiring customs paperwork for worldwide shipment of IP and clinical trial materials. Coordinate with international Qualified Persons for release of IP for use.
  • Provide oversight to contract manufacturing organizations (CMOs) for labeling and packaging, drug depot service, and transportation logistics coordination.
  • Communicate clinical packaging plans to applicable contract packaging sites, and ensure effective management of clinical packaging site activities.
  • Work within established timelines of IP manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines.
  • Lead trouble shooting effort for investigational product shipment issues.
  • Assess, manage, and track the purchase, distribution and labeling of comparator products and other miscellaneous ancillary clinical trial material.
  • Manage and track IP inventory; advise management team of potential shortages and make recommendations for resupply activities based on usage trends and forecasting.
  • Develop, manage, and utilize appropriate inventory reporting tool(s), for maintaining clinical supply inventory and forecast records.
  • Review and provide input and approval for set up of user requirement specifications for Interactive Response Technology systems.
  • Collaborate with Clinical Operations, packaging CMOs, ALX QA, and regulatory agencies to develop regulatory compliant labels for finished product including the development and approval of label text and label proofs, and country-specific translations.
  • Own the clinical IP demand forecasting, clinical demand planning and clinical inventory planning. 
  • Develop the program level demand planning forecasts and budgets for clinical drug supplies through all phases of clinical development.
  • Collaborate with Clinical Trial Managers and Project Leads to gather and identify demand assumptions, such as enrollment rate, number of sites, number of countries, project / product clinical trial forecast requirements and demand history data, and generate / revise clinical trial inventory forecast requirements for planning purposes.
  • Actively participate in project team meetings to collaborate with cross-functional team members from Technical Development, Clinical Operations, Regulatory Affairs, and Quality Management to communicate status reports and address issues.

Requirements

  • Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
  • Strong communication skills, both written and verbal, to interact effectively with all stakeholders.
  • Ability to lead and challenge multifunctional teams, facilitate decision-making, work effectively in cross-cultural environments.
  • Strong working knowledge in common computer programs (e.g., Word, Excel, PowerPoint, Project, Google platform).
  • Strong analytical and organizational skills with excellent attention to detail.
  • General knowledge of current GMP/GCP/GDP regulations for IP, with proficiency in international labeling and packaging.
  • Strong working knowledge of labeling, packaging, and distribution of IP related material.
  • Travel (up to 10% of time) as required to CMOs and key service providers.
  • May be remotely located.

Education & Experience

  • Bachelor’s degree in an applicable discipline.
  • Minimum 7 years related experience in clinical supply management or equivalent experience in the pharmaceutical / biopharmaceutical industry, with minimum of 3 years experience in clinical trials supply management, packaging, and labeling.
  • Experience in clinical supply forecasting, with proficiency with Excel modeling or other supply planning systems.
  • Supply chain/distribution logistics/import export/customs experience.
  • Significant experience working in an outsourcing vendor management experience environment.
  • Experience in Chemistry, Manufacturing and Controls (CMC) fields is a plus.

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com.