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Korro Bio, Inc. · 13 hours ago

Senior Manager, Clinical Operations

60 First St, Cambridge, MA 02141

Full-time

Onsite

Senior Level, Lead/Staff

$163K/yr - $187K/yr

8+ years exp

Korro Bio is a biopharmaceutical company focused on developing innovative genetic medicines. The Senior Manager of Clinical Operations will lead early phase clinical trials, ensuring compliance and collaboration with stakeholders, while optimizing trial design and execution.

BiotechnologyHealth CarePharmaceutical

Responsibilities

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%)

Qualification

Clinical operations leadershipGlobal clinical studiesRegulatory compliance knowledgeEarly phase trials experienceCross-functional team leadershipCommunicatorStrategic thinkingProblem-solving skills

Required

Bachelor's Degree; Life Sciences preferred. Advanced degree desirable

8+ years of relevant clinical development and operations experience, in clinical operations leadership roles, leading global clinical studies/programs, with track records of initiating and delivering early phase trials

Experience in rare diseases and early phase studies (including FIH studies) is highly desirable

Strong leadership skills driving large cross functional teams

Deep knowledge of global regulatory and compliance requirements for clinical research, local country requirements and ICH GCP, including experience with global regulatory inspections

Excellent critical and strategic thinking, with strong ability to understand the big picture as well as the important details that may impact the big picture

Global clinical operations & development experience across therapeutic areas with demonstrated ability to rapidly learn new indications

Excellent communicator and influencer, able to persuasively convey ideas and data, verbally and in writing