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.
We are seeking a highly motivated individual, with the relevant background and experience, who enjoys cross-functional collaboration and continuous learning in a fast-paced environment to join Akouos’s Research & Development team. The Nonclinical Operations Manager will support Akouos’s projects in nonclinical stages, ranging from newly identified target opportunities to IND-enabling studies. This role reports to the Director of Anatomy & Physiology and provides support to the broader Nonclinical R&D teams.
- Review study documentation and ensure adherence to protocols and procedures. Manage the tracking of overall study quality, including deviations.
- Participate in project and program team meetings to understand operational and regulatory requirements and timelines for deliverables.
- Develop and implement an efficient scheduling system to track the entire workflow of nonclinical studies.
- Develop and implement new processes and procedures to support both compliance and efficiency across Nonclinical R&D teams as needed.
- Play an active role in monitoring compliance with study protocols.
- Develop and implement a new system to organize, archive, and maintain accurate and up-to-date databases for specimens and other materials for Nonclinical R&D teams.
- Manage, author, and review reporting of nonclinical studies.
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.
- BS in life/health sciences required; PhD preferred.
- 2 to 3+ years related experience (e.g. preclinical/translational sciences, auditory science, project management, healthcare, and/or clinical research experience); experience in the biotechnology/ pharmaceutical industry preferred.
- High attention to detail.
- Meticulous document management practices
- Project management experience strongly preferred.
- Successful performance managing multiple tasks and projects; excellent organizational skills.
- Creativity; excellent problem identification and problem-solving skills; ability to exercise judgment independently.
- Demonstrated ability to work well in a collaborative and dynamic team environment.
- Strong communicator and facilitator.
- Proficient in Microsoft Office suite and knowledge of project management software.
- Demonstrated ability to learn and manage new systems quickly.