Associate Director, Supply Chain Management

Key Responsibilities

• Develop and execute global supply chain strategies aligned with corporate and clinical development goals.
• Work with cross functional teams to develop clinical forecast / demand plans based on trial requirements. Routinely identify risks, mitigation plans and implement solutions.
• Manage packaging, labeling, distribution, and returns of IMP/CTM with external vendors in compliance with cGMP and global regulations. Manage creation of label text/translation and design of study drug packaging in compliance with country-specific regulations and study requirements.
• Ensure on time delivery of clinical supplies to depots and sites in accordance with each clinical protocol.
• Develop IRT (IXRS) supply and return strategy, lead the IRT set up, and participate in User Acceptance Testing (UAT) where needed.
• Oversee shipping of temperature-sensitive DS/DP/related products across different countries/borders, ensuring compliance with cGMP, GDP, and country-specific requirements.
• Manage temperature excursions associated with shipping & handling of DS/DP/CTM/IMP. 
• Author study specific pharmacy manuals and supply related training/instructional materials (e.g. IM and SIV slides, dosing cards, accountability forms).
• Develop requirements/specifications for clinical study drug and other drug supply as required, including packaged product specifications and product shipping & storage specifications.
• Collaborate with Quality Assurance on vendor qualification and audits.
• Support regulatory submissions (IND/IMPD/CTA/etc) and ensure inspection readiness for global regulatory audits.
• Maintain documentation and SOPs to support compliance and continuous improvement.
• Stay current on all Korro Bio SOPs related to CTM/IMP distribution and follow procedures for the release of IMP to clinical sites.
• Develop clinical supply budget/forecasting and track invoices to contracts.

Qualifications

Bachelor’s or advanced degree and a minimum of 10 years of relevant experience in pharmaceutical/biotech industry.
Experience in clinical trial supply sourcing and management required.
Experience setting up and managing shipments and inventory in IRT/IXRS systems.
External vendor management experience required.
Supply chain/distribution logistics, import/export/customs experience required.
Experience with cold chain distribution.
Knowledge of regulatory requirements for IMP/CTM.
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.