Korro Bio, Inc.

Associate Director, Clinical Supply

Korro Bio, Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Senior

About the role

  • Manage investigational products supporting clinical development pipeline and studies, ensuring on-time delivery of study drug to participants and overall clinical supply chain management (packaging, labeling, distribution, inventory management, returns, and destruction of IMP/CTM)
  • Develop clinical forecast / demand plans based on trial requirements; identify supply chain risks and implement mitigation plans
  • Work with cross-functional teams to define clinical supply plans and provide clinical supply status reports
  • Review clinical protocols for study supply requirements and contribute to study drug packaging design
  • In collaboration with quality, create label text in compliance with regulations and manage translations and country-specific requirements
  • Manage vendors for labeling, packaging, and global distribution of investigational product and ancillary supplies
  • Develop IRT (IXRS) supply and return strategy, lead IRT/IXRS setup, and participate in User Acceptance Testing
  • Manage evaluation of temperature excursions and cold-chain logistics
  • Develop requirements/specifications for clinical study drug and other drug supply, including packaged product, shipping and storage specifications
  • Contribute to study-specific pharmacy manuals and supply-related training/instructional materials
  • Coordinate with Supply Chain for use of commercial products in clinical environment
  • Stay current on Korro SOPs related to CTM/IMP distribution and follow procedures for release of IMP to clinical sites
  • Develop clinical supply budget and forecasting and track invoices to contracts
  • Provide Regulatory Affairs with applicable information or sections for IND/IMPD/CTA/etc. submissions
  • Report to VP Clinical Operations and interact with Technical Operations, Clinical Development, Quality, Regulatory, and external vendors

Requirements

  • Bachelor’s Degree and a minimum of 8 years’ professional experience, or equivalent experience
  • Experience in clinical trial supply sourcing and management
  • Supply chain/distribution logistics/import export/customs experience
  • Experience with cold chain distribution and ultra-cold products
  • Knowledge of regulatory requirements for IMP
  • Experience setting up and managing shipments and inventory in IXRS/IRT systems
  • External vendor management experience
  • Excellent written and oral communication skills
  • Ability to work independently with minimal oversight
  • Strong interpersonal skills and ability to function in a dynamic team environment
  • Strong computer skills, with proficiency in spreadsheet, presentation and word processing software
  • Flexibility to travel on company business as required