Korro Bio

Associate Director, Clinical Supply Chain Management

60 First St, Cambridge, MA 02141 · Director

Sponsorship not specified$150k-$200kDetected 43 days ago

ComplianceSupply ChainLogisticsInventory ManagementGMPFDA RegulatoryCommunicationRegulatory Affairs

About the role

The position will lead the strategic and operational management of complex clinical supply activities across all phases of development to provide life-changing therapeutics for patients.
This role collaborates with Clinical Operations/Development, Quality, Regulatory Affairs, and external partners to manage supply planning, inventory management, and distribution & logistics aligned with GMP and regulatory guidelines.
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 implement end to end supply chain strategies from raw material to finished goods, aligned with corporate and clinical development goals.
Work closely with clinical operations/development to develop clinical forecasts/demand plans based on clinical trial requirements, while optimizing supply chain operations to ensure timely availability of investigational medicinal product (IMP)/clinical trial material (CTM).
Establish and manage vendor relationships for outsourced supply chain services. Develop budget and track invoices to contracts.
Manage labeling, packaging, distribution, and returns of IMP/CTM with external vendors in compliance with GMP and global regulations.
Manage creation of label text/translation and design of study drug packaging in compliance with country-specific regulations and study requirements.
Develop Interactive Response Technology (IRT) supply & return strategy, lead/oversee the IRT set up, and participate in User Acceptance Testing (UAT) where needed.
Manage temperature excursions and support investigations & CAPA to ensure uninterrupted supply.
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.

Bachelor's or advanced degree with a minimum of 10 years of relevant pharmaceutical/biotech experience in supply chain management and operations.
Experience in managing activities for global clinical trial supply, including but not limited to labeling, packaging, distribution, and IRT/IXRS inventory management in compliance with GMP and global regulations.
Strong understanding of global regulatory requirements for IMP/CTM.
Excellent written & verbal communication with 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.
Develop requirements/specifications for clinical study drug and other drug supply as required, including packaged product specifications and product shipping & storage specifications.

Experience with global supply chain, material movement, cold chain distribution, and logistics.
Experience with trade compliance and import/exports/customs requirements is a strong plus.

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 acc

We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases.
Join us as we redefine what's possible in genetic medicine and work to make a lasting impact on human health.

Oversee shipping & handling of temperature-sensitive DS/DP/IMP & related products across different countries/borders, ensuring compliance with cGMP, GDP, and country-specific requirements.
We are collaborative and united by a common mission.
Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization.

This listing is sourced directly from Korro Bio's careers page and normalized into a canonical job model.