Manager, Clinical Supply Chain Mgmt

vor 1 Woche

Zug, Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit
This role is based in our Lexington office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities _(including, but not limited to)_**:

  • Ensure continuous supply of clinical trial material for assigned studies globally
  • Ensure ontime startup of new studies by having supplies available as required
  • Manage clinical packaging and distribution vendors
  • Design and execute packaging and labelling campaigns
  • Support the procurement, labeling and distribution of comparators
  • Review clinical protocols and design appropriate supply chain strategy
  • 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 globally
  • 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
  • Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
  • Manage study closeouts and drug reconciliation at study end
  • Ensure all clinical supply related documents are filed in the eTMF
  • Develop and manage clinical supply budget for assigned studies
  • Oversee Clinical Supply Chain timelines to ensure ontime completion of deliverables

Qualifications:

  • Requires a BS degree with 3+ years' experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment
  • Experience managing contract packaging and labeling organizations
  • Experience with developing riskbased supply strategy for an early to latestage 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
  • Global distribution experience including working with QP, IRT and regional depots.
  • Excellent project management and communication skills
  • Must thrive in a fastpaced innovative environment while remaining flexible, proactive, resourceful, and efficient
  • Strong commitment to compliance and ethical standards
  • Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
  • This position does not require travel

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