Jon Brudvig, PhD

US Fabry Medical Director | Rare Disease & Translational Science | Evidence Generation, KOL Strategy, Global Development & Launch

Sioux Falls, South Dakota, United States

About

I’m a medical affairs and translational science leader with deep experience in rare diseases, evidence generation, and physician engagement from preclinical through commercial stages. My work sits at the intersection of science, medicine, and strategy, translating complex biology into clinically meaningful evidence that supports regulatory interactions, informs physician decision-making, and strengthens payer understanding. I partner closely with R&D, clinical development, regulatory, and commercial teams to support global launches, lifecycle strategy, and indication expansion in rare and specialty diseases.

Experience

  • Amicus Therapeutics (Full-time · 5 yrs)
    • Senior Medical Director, US Fabry
      Dec 2025 - Present · 7 mos

      I currently serve as the US Regional Medical Lead for Fabry Disease, providing strategic medical leadership across evidence generation, scientific engagement, and medical communications. I partner closely with Global Medical leadership and international colleagues to develop and execute aligned medical strategies for the US. I represent US Medical Affairs in global governance forums and cross-functional leadership teams, translating scientific strategy into executable US medical plans. I lead US initiatives spanning diagnosis and patient identification, investigator-initiated research, real-world evidence, Phase II-IV studies, and publication planning to address key evidence gaps in Fabry disease. I work closely with Medical Affairs, Marketing, Patient Advocacy, and the MSL organization to ensure scientific rigor, compliance, and high-quality internal and external medical education, while also maintaining strong partnerships with national and global Fabry key opinion leaders, Centers of Excellence, and patient advocacy organizations.

    • Senior Director, Scientific Evidence
      Jul 2021 - Jan 2026 · 4 yrs 7 mos

      In this role, I provided scientific and evidence-generation leadership across rare disease programs, with a focus on translating biology into clinically meaningful outcomes. Reporting to the Chief Science Officer, I led cross-functional teams spanning preclinical research, biomarker strategy, and external partnerships to support indication strategy, evidence development, and clinical advancement. I played a central role in evaluating and advancing new indications and expansion opportunities by integrating preclinical, translational, and early clinical data. I contributed to global evidence generation and publication planning efforts, working closely with Clinical, Medical Affairs, and external collaborators to ensure scientific rigor and clinical relevance. Key contributions included leading the discovery and validation of novel disease biomarkers, progressing work from animal models into clinical programs and supporting their adoption as exploratory and secondary endpoints in clinical studies. I also supported the advancement of multiple therapeutic candidates into IND-enabling and clinical studies by aligning translational data packages with downstream clinical and regulatory needs.

  • Visiting Scientist at Sanford Research
    Dec 2019 - Present · 6 yrs 7 mos

    In this role, I manage preclinical science for a portfolio of rare disease therapeutics in collaboration with industry partners, leading a large team of associate- and senior-level researchers and managers. Focus areas include lysosomal storage disorders and neurodevelopmental disorders, and treatment modalities range from small molecules to gene therapies. Key accomplishments include: - Mentorship and training of effective leaders and managers. - Implementation of lean engineering work flows. -Discovery and development of four new targets and four IND-candidates for lysosomal storage disorders. -Inventor on multiple patents for novel therapeutics. -Discovery and validation of novel biomarkers for Batten Disease.

  • Assistant Professor, Pediatrics at The University of South Dakota, Sanford School of Medicine
    2020 - Present · 6 yrs 6 mos

    Serving the goals of the department through teaching, service, and research. Instructor for the Molecular Mechanisms of Disease course in the graduate program in Basic Biomedical Sciences.

  • Senior Editor - The Vector at American Society for Gene & Cell Therapy (ASGCT)
    Feb 2020 - Feb 2025 · 5 yrs 1 mo

    The Vector is the official newsletter of the American Society for Gene & Cell Therapy (ASGCT). In this role, I highlight recent progress in gene and cell therapy by creating content for the "Breaking Through" series and by curating a list of recent influential articles.

  • Technical Writer at Johnson & Johnson
    Apr 2019 - Apr 2020 · 1 yr 1 mo

    Managing regulatory writing projects for regenerative cell therapies and other orthopedic medical devices marketed in the European Union (EU).