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 individuals who live with disabling hearing loss worldwide.
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 pharmacologic 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 Director of Nonclinical Regulatory Affairs to lead the nonclinical regulatory strategy and support nonclinical development for a variety of pipeline projects and development programs.
The successful candidate will help to advise both the Translational and A&P teams in development especially in the following areas: protocols and reports, regulatory filings (nonclinical sections), IB and labelling. They will also lead the development of the nonclinical portions of regulatory filings. The individual will be self-motivated, with a desire to succeed at the highest level, collaborating closely with a team of scientists aiming to develop therapies that have the potential to restore and preserve hearing. A background in gene therapy is highly desirable and a proven ability to deliver novel therapeutic approaches into the clinic is essential.
- Lead the development and implementation of document strategy for the nonclinical aspects of all regulatory filings, including Module 2 summaries, pre-IND and scientific advice briefing documents, and Investigator’s Brochures.
- Advise Program Teams on the regulatory considerations for design and execution of GLP and non-GLP study designs.
- Design, execute, and interpret complex projects and deliverables, data analyses, and preparation of presentations and reports.
- Provide input into final design, protocol development, execution, monitoring, and reporting of all pharmacology, biodistribution, safety/toxicology and dose range-finding studies with our gene therapies.
- Reinforce consistent messaging across regulatory submissions (nonclinical) and IND-enabling non-clinical study reports.
- Present analyses and interpretations of nonclinical studies to regulatory agencies and other oversight bodies in meetings and documents including scientific advice proceedings, IND/CTA applications, annual reports, safety reviews, investigator brochures, and market applications.
- Build cross-functional relationships with internal teams and CROs facilitating logistics and communication.
- Some travel will be required.
- Ph.D. or equivalent degree in biomedical sciences, preferably with focus on translational research and/or toxicology;
- Experience directly contributing to nonclinical sections of regulatory documents (e.g., for a Toxicology, Pharmacology, Nonclinical, Translational, or Regulatory group)
- Comprehensive experience with biochemistry, cellular biology, and/or molecular biology.
- Experience with GLP regulations and reporting requirements.
- Hands-on preclinical research experience in animal studies.
- Ability to multi-task and manage several projects in parallel, paying attention to detail.
- Progressive record with proven successes in translational development and/or regulatory affairs with a focus on translational research.
- Demonstrated excellent analytical, interpersonal, written, and oral communication skills. Ability to communicate effectively with scientists and with non-scientists.
- Highly effective presentation skills.
- Proven ability to thrive in a fast-paced, entrepreneurial yet highly disciplined start-up environment
- Gene therapy experience (especially AAV or other viral platforms).
- Experience on a regulatory team.