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Manager, Clinical Supply Chain

Cambridge, MA 02139

Posted: 01/14/2020 Employment Type: Direct Hire Job Category: Clinical: Supplies/ Logistics Job Number: 2494

Job Description


Our client is seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment. In this role, you will manage all aspects of the clinical drug supply chain, including creation, execution and maintenance of the clinical drug supply strategy and associated budget management.    You will collaborate closely with the internal clinical supply chain team, cross-functional team members and CMO/CRO/IRT vendors. As the Clinical Supply Manager (CSM), you will manage drug product manufacture and label/pack/distribution at multiple CMOs and IRT system development/maintenance with vendors to ensure uninterrupted drug supply for global clinical trials.

Responsibilities:
  • Manage supply chain CMOs to develop labeling/packaging materials, development of compliant country label text and the manufacture, storage and cold chain distribution of clinical trial materials via primary and secondary depots.
  • Design IRT systems for new protocols and maintenance of existing ones, managing threshold levels, generation of manual shipments and disposition of quarantined materials, as needed. Organize UAT testing of IRT systems at kick off and system enhancements needed based on protocol changes
  • Management of multiple IRT vendors/systems working as primary contact from an operational perspective. Developing the system to match the needs of internal cross-functional groups for proper data collection representing Clinical Operations, Data Management, Biostatistics, Safety and Quality, acting as the single point of contact on behalf of the internal teams
  • Identify, evaluate, request proposals, possibly audit and select appropriate Contract Manufacturing Organizations and IRT vendors to meet  business needs

Requirements/Qualifications:
  • B.S./M.S. in a scientific field-Additional Project Management Training (PMP) would be beneficial
  • Seven (7+) years of experience in managing Phase 1-Phase 3 global clinical supply chain in the Pharmaceutical and/or Biotech industry, either as a sponsor, vendor or CRO.
  • Experience with combination drug products (drug + device) and commercial Supply Chains in various global markets.
  • Experience managing vendors with strong understanding of regulatory requirements and guidelines governing labeling, packaging and distribution of clinical trial materials US/EU/ROW/Japan and Global country requirements (FDA/EMA/ICH)
  • Knowledge of proper GMP/GXP trial documentation and identify what is required to be stored in the Trial Master File (TMF) regarding Supply Chain documents
  • Cold chain product management, experience with forecasting tools, deep understanding of GMP/GXP requirements and development/implementation of sponsor internal processes & SOP’ s for greater compliance and efficiencies are a plus
  • Ability to strategically plan, organize and manage multiple projects simultaneously
  • Ability to prioritize tasks/issues and identify them in the future, raising awareness to potential issues in a proactive manner. Strong work ethic to meet deadlines and be flexible on the potential occasion you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline.
  • Ability to creatively solve Supply Chain issues
  • Big picture understanding of the complete Drug Supply Chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant Drug Release approvals and Global Importation logistics process
  • Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations. Effective listening, evaluation of issues and communication of mitigations. Professional, honest, accountable, dedicated
  • Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with automated inventory systems, forecasting software and Oracle Inventory is a plus
  • Ability to work full-time, on-site during core corporate hours at offices in Cambridge.

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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