Associate Director, Clinical Supply Chain

Company: Akebia Therapeutics
Location: Cambridge
Posted on: August 6, 2022

Job Description:

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.
At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Our tenacious, passionate employees challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.
This is life-changing work, and we are all in, are you?
The Clinical Supply Chain Associate Director plans, establishes and monitors the global clinical supplies strategy for protocol development, at the study level, to ensure appropriate processes are established, in order to achieve the clinical supplies key deliverables for each study, within each program. The CSAD is accountable for driving the drug supply material planning, at the study level, for global clinical studies using investigational product, commercial and comparator material in collaboration with the global clinical teams. The Clinical Supply Associate Director monitors inventory levels of clinical supplies as well as key intermediates and manages the processes to maintain targeted inventory at clinical sites. The CSAD will assist in development of supply chain strategies for global clinical trials including investigational products, placebos and comparators. This role will also lead and develop Master Data Management (MDM) as products transition from Clinical to Commercial. The CSAD will participate in SIOP process and coordinate with Supply Chain Data Analytics Team.
TheCSAD will:

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• Be responsible for implementation of clinical supply plans, based on clinical study protocol and clinical development plans.
  
• Collaborate with Clinical Trial Managers, clinical packaging sites, applicable internal functional areas, CROs, and others as applicable to evaluate and maintain up-to-date status records and reporting for all clinical supply-related activities across projects / products.
  
• Develop and maintain information and reporting, in collaboration with QA, to ensure transparency of project / product current expiry periods.
  
• Collaborate with Clinical Operations, packaging CROs, QA and regulatory agencies to develop regulatory compliant labels for finished product.
  
• Develop integrated plan to ensure uninterrupted supplies throughout the duration of a clinical study program.
  
• Collaborate with Clinical Trial Managers to develop the drug distribution strategy for each trial and lead the development.
  
• Review IRT specifications and perform acceptance testing of IRT when applicable.
  
• Work with IRT systems and monitor the site and depot inventory levels and settings; provide oversight to site and depot shipments; place manual orders as needed.
  
• Develop and maintain applicable metrics to monitor performance relative to clinical trial inventory and planning.
  
• Collaborate with Clinical Trial Managers and Project Leads to both gather project / product clinical trial forecast requirements and demand history data, and generate / revise clinical trial inventory forecast requirements for planning purposes.
  
• Work with external consultants and third-party vendors to ensure timely and quality delivery of CTM that meets study protocol, regulatory, and budgetary requirements.
  
• Ensure that key project milestones are met; negotiate and communicate supply plan timelines to internal and external partners.
  
• Develop Clinical Supply related SOPs.
  
• Provide CMO's and CRO's appropriate production forecasts and Purchase Orders.
  
  Basic Qualifications:
  
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  • Bachelor's degree in Supply Chain, Business, Engineering, Scientific Discipline, Nursing, or Pharmacy
    
  • 7+ years of work experience within a clinical Supply Chain function in a biotech or pharmaceutical environment.
    
    Preferred Qualifications:
    
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    • Demonstrated track record of creativity and problem solving within a regulated environment
      
    • Ability to exercise independent judgment with minimal supervision
      
    • Demonstrated ability to work effectively in a global/matrix environment
      
    • Strong organizational and forecasting skills.
      
    • Proficiency with clinical supply planning, forecasting, and inventory reconciliation.
      
    • Experience with master data management.
      
    • Experience with CRO's and Clinical Protocols/Labeling.
      
      Travel Requirements:
      
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      • Travel domestically and internationally, as needed.
        
        Are you an Akebian?
        An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website:
        COVID 19 Vaccination:All Akebia new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Akebia will consider, among other things whether a proposed accommodation would create an undue hardship. Please note that it is unlikely that accommodations can be granted for customer-facing positions.
        Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Keywords: Akebia Therapeutics, Cambridge , Associate Director, Clinical Supply Chain, Executive , Cambridge, Massachusetts