Korro Bio, Inc.

Supply Chain

• 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
• 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
• Develop requirements/specifications for clinical study drug and other drug supply as required
• 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

Associate Director, Supply Chain Management

Director

• Manage all data management (DM) tasks for clinical programs from study startup through database closure and archival, producing high-quality databases for analysis and potential regulatory submissions.
• The person in this role must have experience in a regulated environment and be prepared to present data and documentation in support of regulatory requirements for complete and accurate data.
• Manage the Data Management function at Korro and author, review, publish, and review policies and methods in standard operating procedures, work instructions, job aids, and other training documents.
• Work closely with cross-functional members of the study team, including Clinical Development, Biostatisticians, Statistical Programmers, Pharmacovigilance, Regulatory, Translational Research and Clinical Operations.
• Provide representation, and guidance to the internal and external teams as the clinical data management subject matter expert for assigned program/studies.
• Serve as a subject matter expert for various operations, including, but not limited to, electronic data capture, external data standardization, collection, and processing, and the creation of standard data collection forms and associated validation checks and collection processes.
• Oversee CRO data cleaning activities including processing queries, performing ongoing data review, identifying and tracking data issues and trends to give transparency to Global Development Program Leads, and other program team members.
• Provide input into study protocols, SAPs, and other clinical documents, to ensure quality data collection and management.
• Map data flows, processes and systems used for collection, management and provision of data to downstream functional area users.
• Contribute to data management deliverables including Data Management Plans, Data Validation Manuals, CRF Completion Guidelines, Data Transfer Specifications, Lab Specifications, etc.
• Support vendor UATs for database builds and or migrations to manage any impacts from mid-study updates to the EDC database.
• Meet with global regulatory agencies and mock auditors in quality, performance, and system audits and inspections and ensure inspections meet department performance metrics through pro-active compliance and quality measures.
• Develop data management standard working practices along with preparations and requirements for regulatory submissions and inspections.
• Establish data transfer guidelines for external data with CRO and vendor partners; reconcile and ensure transfers are executed to plan.
• Reconcile electronic data transfers from external vendors (e.g., IXRS, specialty labs, etc.) to the sponsor and/or oversee study data reconciliations performed by the CRO.
• Assume ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures.
• Coordinate with CRO on presentation of data metrics, trending and reports for data review meetings with internal stakeholders to ensure ongoing data integrity and proactive quality measures are employed to identify data issues.
• Assist in defining data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audits.
• Support close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
• Contribute to data system compliance by following the established guidelines of national and international regulatory authorities.

Associate Director, Supply Chain Management

Director, Clinical Data Management