Senior Manager, Clinical Scientist
About The Position
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 2â5 years of Clinical Scientist experience in the biotechnology and/or pharmaceutical industry.
- 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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
