Manager, Clinical Supply Chain

Job Locations US-MA-Bedford
Posted Date 3 months ago(4/16/2021 8:25 AM)
Job ID
2021-1432
# of Openings
1
Category
Operations

Overview

Responsible for management and oversight of end-to-end clinical supply chain activities for assigned clinical protocols/programs. Day-to-day activities involve managing the supply of Investigational Product (IP) through all stages of clinical development including packaging, labeling and distribution. Work closely and collaborate with clinical and CMC teams to ensure on-time supply of product for ongoing and new clinical trials including demand forecasting, trial monitoring, resupply planning, IRT set-up and distribution activities. This position reports to the Senior Manager of Clinical/Commercial Supply Chain.

Responsibilities

  • Identify clinical supply requirements and develop clinical supply plans for initial and subsequent packaging/labeling operations based on clinical protocol and enrollment forecast in collaboration with Clinical Operations.
  • Design and execute packaging and labeling campaign activities including but not limited to: timeline management, documentation approval, risk mitigation, coordination with internal manufacturing operations and external Contract Development and Manufacturing Organizations (CDMO).
  • Manage Interactive Response Technology (IRT) contracting, specification development, user acceptance testing (UAT) and system oversight for assigned protocols.
  • Track study status in IRT and intervene as necessary to ensure supply availability at clinical sites. Troubleshoot problems with IRT as they arise, collaborating with IRT vendor as necessary.
  • Drive label creation and approval process, including translations and regulatory requirements.
  • Ensure continuous supply of clinical trial material for ongoing studies and on-time delivery of IP for new study start-up.
  • Support return and destruction of clinical trial material.
  • 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.
  • Work collaboratively and transparently with Clinical Operations, Manufacturing, Quality Assurance, Regulatory Affairs and Project Management.
  • Generate and review procedures and processes as required to ensure compliance to relevant SOPs, regulations, and laws.

Qualifications

 

  • BS degree in with 4-6 years’ experience in a Supply Chain Planning role in a Biotechnology or Pharmaceutical environment.
  • Excellent project management, organizational and communication skills.
  • Experience with developing risk-based supply strategy for early to late-stage clinical development programs.
  • Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Experience managing contract packaging and labeling organizations.
  • Experience with clinical trial start-up and customized IRT systems.
  • Experience in cold-chain clinical supply distribution is a plus.
  • Understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements.
  • Understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.

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