Korro Bio, Inc.

Clinical Operations

• Plan, drive and oversee all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines in close collaborations with key stakeholders and Clinical Research Organizations (CROs)
• Drive implementation of clinical operational strategy for successful delivery of assigned clinical studies
• Use operational and therapeutic expertise to optimize trial design and execution and collaborate with the study team to accelerate clinical trial timelines
• Provide oversight and management for all relevant CROs and vendors including contracting and clinical budgets; develop contingency plans for clinical trials
• Coordinate and lead study team meetings and update the Program Team on timelines and milestones for the study
• Contribute to the development of study documentation including protocol review, creating study plans, ICFs, and designing CRFs
• Contribute to CRO/vendors identification, qualification and selection processes as applicable
• Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting
• Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data
• Oversee high quality implementation, execution and delivery of studies by CROs in alignment with timeline and budget plan
• Establish an open team culture defined by transparent communication, clear goal setting, and risk-based oversight
• Ensure compliance with internal policies and procedures, GCPs, and applicable regulations; ensure inspection readiness
• Oversee Vendor Contracts and Clinical Study Budget, report progress to finance team
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
• Oversee TMF management and review TMF documentation as necessary
• Limited travel possible to field sites to supervise and/or monitor clinical studies (<25%)

Senior Manager, Clinical Operations

Director

• leading for all aspects of analytical development related to both drug substance and drug product components of the modalities
• responsible for the deployment of methods for routine analysis of oligonucleotides to advance our RNA editing drug discovery platform and programs
• play a key role in advancing a pipeline of products from the early stage drug development to market approval
• require leadership across a matrixed analytical organization, effective collaboration with other CMC functions, close management of CDMO activities, and significant contribution to the overall CMC strategy for the program
• Deep knowledge of cGMPs and regulatory guidelines, significant experience in the CMC development of oligonucleotide and considerable expertise in the analytical techniques and strategies commonly used in the development of oligonucleotides is essential.
• express a high attention to details, be comfortable multitasking in a fast-paced startup environment

Director, Analytical Development

Clinical Research

• The Clinical Scientist will work closely with the clinical development department to provide support in one or more Clinical Project Teams at Korro Bio in order to ensure the successful design and implementation of Clinical Development Plans.
• S/he is responsible for effective scientific oversight of studies (in partnership with study / program medical director and clinical operation team members)
• support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions)
• Major areas of responsibility include contributing to clinical trial design/protocol writing and execution of Company-sponsored clinical trials at all phases of development
• clinical trial data analysis
• internal and external communication of project plans and progress
• safety monitoring and mitigation
• key contributions to regulatory submissions, publications, and clinical data communications.

Senior Manager, Clinical Operations

Director, Analytical Development

Senior Manager, Clinical Scientist