СШАSenior Clinical Trial Manager
4 нед. назад
163.3k–186.7k USD / годСШАSeniorHybrid
Manage clinical trials for biopharmaceutical genetic medicine development focusing on RNA editing.
О компании
- 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. We are collaborative and united by a common mission. We are building a company with extraordinary people with an audacious vision to create transformative genetic medicines for prevalent diseases. Our values - Rewrite the future, On the Cutting Edge, Better Together, Dynamically Different, Kindness and Integrity form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Korro is a magnet for outstanding talent and a great place to work. Join us as we redefine what's possible in genetic medicine and work to make a las
Обязанности
- 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%)
Требования
- 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