Jonathan R. Morgan, MBA

Director, Regulatory Project Management and Operations at Akouos

Jonathan R. Morgan, MBA has a diverse work experience spanning several industries.

Starting in 2014, they worked as an Undergraduate Research Assistant at Roanoke College, where they conducted research on the role of the CG12082 gene in cell cycle regulation. Jonathan R. genetically engineered fruit flies with a mutation in the gene and utilized molecular biology techniques to validate the success of the mutations.

In 2015, Jonathan worked as a Research Associate at Carilion Clinic, participating in a clinical trial on trends in emergency department management of skin abscesses. Their responsibilities included patient recruitment, informed consent conversations, and data collection.

Moving into the pharmaceutical field, Jonathan joined PAREXEL in 2016 as a Clinical Monitoring Associate. Jonathan R. oversaw and managed 25 clinical investigation sites in large Phase 3 clinical trials for a new iron deficiency anemia therapy. Additionally, they handled study start-up and monitoring activities while implementing solutions for site and study level issues to ensure quality and prevent project delays.

In 2017, they transitioned to the role of Associate Consultant at PAREXEL, managing cross-functional subject matter expert teams to complete various project deliverables related to regulatory marketing applications, pediatric study plans, and risk evaluations. Jonathan R. also performed project management activities, including budget oversight, resourcing, and client meetings, maintaining a high level of customer satisfaction.

Jonathan joined Personal Genome Diagnostics in 2018 as a Clinical Project Manager, where they managed multiple precision medicine clinical and biomarker research studies for pharmaceutical partners. Jonathan R. also directed the transfer of Next Generation Sequencing assays from Research and Development to a CAP/CLIA laboratory for use in clinical trials and patient treatment decisions.

In 2019, Jonathan joined Catalent Pharma Solutions as a Regulatory Affairs Associate II, leading a cross-functional team in developing a compliant quality system at a new manufacturing site. This resulted in a successful regulatory inspection and the establishment of the world's first FDA approved commercial gene therapy contract manufacturing site. Jonathan R. also coordinated communication with regulatory agencies to support approval for the manufacturing site while conducting in-depth analyses for risk identification in critical systems.

At Parexel, Jonathan took on the role of Senior Consultant, Program Lead in 2021. Jonathan R. served as a program lead for various projects, utilizing their regulatory expertise to provide consulting services to clients.

Their most recent position, starting in May 2023, is Director of Regulatory Project Management and Operations at Akouos, where they oversee the project management and operations functions within regulatory affairs.

Overall, Jonathan R. Morgan, MBA has demonstrated a strong background in regulatory affairs and project management across various industries.

Jonathan R. Morgan obtained their undergraduate education at Roanoke College from 2012 to 2016, earning a Bachelor of Science degree in Biology. In 2020, they enrolled at the University of Maryland - Robert H. Smith School of Business to pursue their Master of Business Administration (MBA), which they completed in 2022. No specific field of study is mentioned for their MBA.

Links

Previous companies

Roanoke College logo
Parexel logo
Personal Genome Diagnostics logo
Carilion Clinic logo

Timeline

  • Director, Regulatory Project Management and Operations

    May, 2023 - present

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