Senior Manager, Clinical Scientist

Korro Bio•Cambridge, MA

16h

About The Position

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’s lead program is Alpha-1 Antitrypsin Deficiency (AATD). 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 lasting impact on human health. 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. This role serves to ensure the design of cost-efficient clinical trials to meet the needs of internal and external stakeholders. S/he is responsible for effective scientific oversight of studies (in partnership with study / program medical director and clinical operation team members) and supports 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, and key contributions to regulatory submissions, publications, and clinical data communications.

Requirements

PhD or PharmD is highly desired
A minimum of 2–5 years of Clinical Scientist experience in the biotechnology and/or pharmaceutical industry.
Experience in rare diseases and/or early-stage development is a plus
Comprehensive knowledge of the drug development process
Proficient knowledge of GCP/ICH, study design, statistics and clinical operations is required
Proven experience with clinical data review databases
Excellent verbal, written, and interpersonal communication skills, with the ability to collaborate effectively across functions and all job levels.
Proven scientific writing skills, with the ability to evaluate, interpret, and present complex data clearly and effectively.
Creativity and/ or ability to put innovative approaches into practice in clinical development
Strong sense of teamwork; ability to lead team activities
Exemplary critical thinking, problem solving and decision-making skills
Adaptable, flexible, willingness to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism
Potential for travel (up to 20%)

Nice To Haves

Experience in rare diseases and/or early-stage development is a plus

Responsibilities

Contributing to the design of clinical trials and writing/review of protocol concepts, full study protocols, and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.)
Clinical study data review, data cleaning and performing data analyses
Delivering high quality presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
Providing guidance and/or training for external personnel/parties involved in clinical studies
Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
Monitoring for analyses of emerging safety/tolerability
Provide education support for internal company stakeholders
Provide input and support to the Research and Discovery organization as needed
Work collaboratively with the translational medicine group on the identification, selection, and validation of biomarkers to support the clinical development plans
Facilitate, assist and/or participate in the preparation of clinical study manuscripts with Investigators, internal personnel, and medical writers
Maintain expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and translational teams
Support the organization of expert panels and advisory board meetings to provide input into the clinical plan, study design or data
Collaborating with patient advocacy groups, external investigators, and other stakeholders as needed
Support clinical development team on developing the clinical development strategy

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 account and a Company-funded health savings account and free parking.

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