• Manager/Sr. Manager Clinical Supply Chain

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(2/7/2019 1:36 PM)
    Job ID
    2019-1187
    # of Openings
    1
    Category
    Operations
  • Overview

    The Manager/Sr. Manager Clinical Supply Chain will be responsible for the planning, development, and execution of clinical supply chain activities, manage events of supply partners and is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. They will be working closely and collaborate with Clinical Operations, Quality Assurance and Regulatory Affairs. They will be responsible for day-to-day activities related to managing the supply of Investigational Product (IP) through all stages of clinical development including packaging, labeling and distribution as well as, supporting and advising Clinical Operations, and clinical sites on all aspects of IP as applicable. The successful candidate needs to demonstrate end-to-end clinical supply chain knowledge and performance managing all aspects of clinical supplies in a global trial setting.

    Responsibilities

    • Design and execute packaging and labelling campaign
    • Support the procurement, labeling and distribution of comparators
    • Manage Contract Development and Manufacturing Organizations (CDMO) and provide comprehensive information about clinical supplies
    • Ensure continuous supply of clinical trial material for all ongoing studies within the US and ex-US locations
    • Ensure on time startup of new studies by having supplies available as required
    • Manage clinical packaging and distribution contractors
    • Review clinical protocols and design appropriate supply chain strategy
    • Design specifications for automated randomization and drug supply management systems
    • Oversee a variety of logistics issues, including but not limited to supply chain services, inventory control, import-export, shipment of products and third-party warehousing
    • Act as primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
    • Establish measures and metrics to define manufacturing and supply chain performance and provide recommendations to Management to optimize operations both internally and externally
    • Create supplier relationships and service agreements with cost effective distribution of Clinical Trial Material
    • Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs
    • Interpretation of a protocol or study overview to calculate total demand and forecast over time
    • Managing clinical labeling including label design, translation and production
    • Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
    • Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies
    • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
    • Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
    • Setting up Interactive Response Technology (IRT) Systems with the clinical team, including UAT testing

    Qualifications

    • BS degree with 5 to 7 years’ experience in a Clinical Supply Chain Planning role in a Biotechnology or Pharmaceutical environment. Advanced degree is a plus
    • Experience managing contract packaging and labeling organizations (strongly preferred)
    • Experience with developing risk-based supply strategy for an early to late stage clinical development programs
    • Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
    • Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
    • Experience working with QP, IVRS, IWRS, depots with global IP distribution
    • Excellent project management and communication skills
    • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient

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