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MAP Pharmaceuticals, Inc.

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Position/Title: Senior Clinical Supply Manager

Reports To: Director, Pharmaceutical Development

  1. Function:
    Responsible for supporting all pre-clinical, clinical trial and product programs, as well as coordination of manufacturing activities. Collaborates with Clinical Operations, Quality Assurance, Manufacturing and Program/Project management functions, in addition to outside CRO's and other vendors. The Company's clinical supplies include all pre-clinical and clinical trials materials, such as investigational drug products, devices, drug product comparators, and supporting medical equipment/materials.
  2. Essential Duties and Responsibilities :
    1. Responsible for sourcing, procurement, distribution, returns, and reconciliation of clinical supplies and their associated (complete and accurate) documentation
    2. Is liaison between contract manufacturers, distributors, and the Company, including clinical sites, and ensures all trial materials are delivered to study sites when needed
    3. Responsible for monitoring material inventories (both internally and at suppliers) to prevent supply shortages or incorrect allocations
    4. Develops Standard Operating Procedures (SOP) for kitting and shipping of clinical/pre-clinical supplies and conducts employee and contract supplier training
    5. Designs and implements necessary documentation and supply chain management inventory and tracking tools
    6. Ensures that packaging batch records and other clinical trial materials documents are accurate, complete, and up-to-date
    7. Develops and coordinates acquisition of appropriate clinical supplies packaging and labeling while maintaining compliance with U.S. Food and Drug Administration (FDA) and Good Manufacturing Practices/Good Clinical Practices (GMP/GCP) guidelines
    8. Drives R&D activities forward by improving processes and operations, using creative problem solving to identify areas for improvement and novel research
    9. Evaluates clinical study protocols to determine supply requirements; forecasts and calculates future supply requirements
    10. Manages clinical and pre-clinical supply distribution, site returns, drug accountability, and material disposition/disposal
    11. Manages returns process and assessment and disposition of all device/product/equipment malfunctions, including associated documentation
    12. Evaluates and maintains contact with suppliers for clinical labeling and packaging, including contract management
    13. Provides Clinical Operations with study materials for investigator meetings and site training requirements
    14. Provides study-specific ordering instructions to Clinical Operations and develops study-specific global procurement and distribution strategies
    15. Assists in writing and assembly of clinical supplies section of regulatory submissions
    16. Manages budgeting and project timelines for clinical supplies
    17. Actively participates in weekly planning and scheduling meetings to ensure project needs and priorities are well understood and communicated
    18. Responsible for all cGMP materials inventory and expiry date tracking
    19. Responsible for oversight of cGMP manufacturing schedule
    20. Travel up to 20% of time to vendors, contractors, and suppliers
    21. Able to lift up to 25 pounds infrequently
    22. Complies with MAP Pharmaceuticals' Safety and Corporate policies
    23. Performs other activities as defined by management and project team requirements
  3. Supervisory Responsibilities:
    1. May supervise other employees, primarily in the functional areas of Supply Chain and Packaging and Labeling
  4. Requirements/Experience/Skills:
    1. Education:
      1. BS/BA degree in related discipline and seven years of related experience; or,
      2. MS/MA degree in related discipline and five years of related experience; or,
      3. Equivalent combination of education and experience
      4. Certification in Clinical Supply or Supply Chain operations desireable
    2. Experience :
      1. Experience in medical product/biotech/pharmaceutical arenas
      2. Experienced supporting phase II and III clinical trial programs, preferably in a drug/device, multi-technology environments
      3. Proven knowledge and experience working with different unit operations, preferably spray drying and supercritical fluid apparatus.
      4. Specific experience with clinical trial material procurement

E-mail resume to:

egrimaldi@mappharma.com
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