Associate Director, Clinical Supply Chain - CONTRACT

  • 0 yrs
  • $ Not Disclosed / YEAR

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Job Description



The Associate Director, Clinical Supply Chain will oversee all aspects of clinical supply management including forecasting, packaging, labeling, distribution, monitoring inventory, and vendor oversight.


Key Responsibilities

  • Develop and manage forecasts by creating and reviewing clinical supply demand for clinical trials

  • Work closely with Technical Operations and Clinical Operations teams to ensure timely labeling, packaging and distribution of clinical trial material

  • Ensure continuity of supply by establishing and monitoring an appropriate monthly forward inventory level and advising Clinical Operations team and study sites on inventory levels throughout the trials

  • Identify potential supply risks and develop preventive actions to avoid supply interruptions

  • Collaborate with external vendors to develop and approve specifications and user acceptance testing of IVR/IWR systems, while reviewing and modifying when study plans change

  • Review vendor-generated documentation and collaborate with Quality team to complete final review/approvals

  • Manage vendors and their respective contracts, invoice review, and budget planning

  • Establish workflows and SOPs in accordance with industry best practices


Experience and Qualifications

  • A degree in natural science, engineering, nosiness administration

  • A minimum of 6 years of clinical supply chain experience including phase I & II clinical trials. APICS certification or coursework is preferred

  • Direct experience in planning and overseeing supply for double-blinded placebo-controlled, as well as open label clinical studies

  • Forecast and manage supply needs and distribution

  • Knowledge of global practices governing pharmaceutical drug product manufacturing and conduct of routine clinical trials distribution

  • Clinical supply management including forecasting, labeling, packaging, distribution, expiries, inventory tracking, and managing IRT systems

  • Knowledge of US, EU, and rest of the world clinical supply labeling requirements is required. Knowledge of QP review process for European clinical supplies is preferred

  • Experience with both ambient and cold chain products is preferred