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Associate Director/Director, Gene Therapy Assays

Boston, MA

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living 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. 

Job Summary:  

The Translational Research group is seeking a Director with experience in bioanalysis to manage external assay development activities for IND-enabling studies and clinical trials.  The scope of work includes designing, coordinating and/or overseeing development, qualification/validation, analysis of clinical specimens, and associated reporting. The successful candidate will have a deep knowledge of pharmacology, immunogenicity, and analytical methods. The individual will use scientific judgment to propose new approaches and work with internal program teams and CROs or other vendors to meet key objectives and timelines.  

Job Requirements: 

  • Build and execute a bioanalytical strategy in collaboration with nonclinical, regulatory, and clinical teams. Develop timelines for key projects and identify critical program activities/constraints. 
  • Work with CROs or other vendors on the transfer and/or development and qualification/validation of pharmacokinetic and immunologic methods for IND-enabling studies and clinical trials. 
  • Prepare/review study protocols, comprehensive reports, and sub-reports for nonclinical and clinical assays or studies. 
  • Assist the Head of Translational Research with projects 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. 
  • Coordination and/or preparation of clinical and non-clinical samples testing plans, documentation, and shipments.  
  • Oversee nonclinical and clinical samples testing.  

Job Qualifications: 

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 , with 5 to 8 years in assay development and validation. Experience with AAV therapies and biotech/pharma/CRO is preferred. 
  • Think strategically, drive innovation, and assure that novel methods are applied to assay development. 
  • Experience developing specialized clinical assays using various modalities (e.g., qPCR, MSD, ELISA, ELISpot, flow cytometry). 
  • Experience in managing and outsourcing assay development to CROs and vendors 
  • Experience preparing qualification/validation reports. 
  • Knowledge of GLP, GCLP, and GDP requirements. 
  • Experience drafting regulatory submission documents. 
  • Advanced problem-solving and interpersonal skills. 
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