Associate Director, Supply Chain Management chez Korrobio

Company Summary: Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body’s natural RNA editing process to effect a precise yet transient single base edit. By editing RNA instead of DNA, Korro is expanding the reach of genetic medicines by delivering additional precision and tunability, which has the potential for increased specificity and improved long-term tolerability. Using an oligonucleotide-based approach, Korro expects to bring its medicines to patients by leveraging its proprietary platform with precedented delivery modalities, manufacturing know-how, and established regulatory pathways of approved oligonucleotide drugs. Korro is based in Cambridge, Massachusetts.

The Associate Director, Supply Chain Management will lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients. The position ensures the uninterrupted, compliant, and cost-effective delivery of investigational products to global clinical trial sites. The ideal candidate will bring deep expertise in supply chain strategy, vendor oversight, and cross-functional collaboration, with a strong understanding of GMP, IRT systems, and regulatory requirements.

Excellent written and oral communication skills are required, as is the desire and ability to work in a small, fast-paced, and patient-focused environment.

• 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.

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.

Benefits:  Korro offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, a dependent care flexible spending account and a Company-funded health savings account and free parking.