Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss.
Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes.
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
The Translational Research group is seeking a Senior Scientist with experience in bioanalysis to manage internal and external assay development activities for IND-enabling studies and clinical trials for a variety of projects and programs. The scope of work includes designing, coordinating and/or overseeing development, qualification/validation, analysis of clinical specimens, and associated reporting. The Senior Scientist will have a deep knowledge of AAV vector biology and analytical methods, be able to work independently, and use scientific judgment to propose new approaches. The individual will work with internal project/program teams and CROs or other vendors to meet key objectives and timelines. The individual will be self-motivated, with a desire to succeed at the highest level, working with a team of scientists aiming to develop therapies that have the potential to restore and preserve hearing.
- Develop and execute a bioanalytical strategy in collaboration with nonclinical, regulatory, and clinical teams.
- Work with CROs or other vendors on the transfer or development and qualification/validation of quantitative methods for IND-enabling studies and clinical trials.
- Assist the Head of Translational Research with complex projects and deliverables, data analysis, and preparation of reports and regulatory documents.
- Build cross-functional relationships with internal teams and CROs/vendors, facilitating communication and seamless logistics.
- Develop timelines for key projects, implementing processes, and identify critical program activities/constraints.
- Preparation, shipping, and documentation of nonclinical and clinical samples.
- Some travel may be required.
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- PhD or equivalent, with 5 to 8 years in assay development for potential AAV therapies, experience in biotech/pharma is preferred.
- Think strategically, drive innovation, and assure that novel methods are applied to assay development.
- Experience developing specialized nonclinical and clinical assays using various modalities (e.g. qPCR, MSD, ELISA, ELISpot, flow cytometry).
- Experience in managing and outsourcing research and assay development to CROs and vendors.
- Experience preparing qualification/validation and study reports.
- Knowledge of GLP, GCLP, and GDP requirements.
- Experience drafting regulatory submission documents.
- Experience leading and working on multiple projects simultaneously.
- Advanced problem-solving and interpersonal skills.
- Exceptional written and verbal communication.