Amar A. Sethi

About Amar A. Sethi

Transformational executive with almost 30 years of progressive experience in pharmaceutical R&D, CRO leadership, clinical trials (Phases I–IV), diagnostic development (CAP/CLIA/GCP/GLP), and medical device regulation (510(k)/PMA). Combines deep clinical acumen with business and regulatory strategy to lead early-to-late-stage drug development, translational medicine, biomarker platforms, and precision diagnostics. Proven success in leading FDA breakthrough and orphan programs, BLA/NDA submissions, and strategic portfolio advancement across lipid biology, metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular disease. Adept at bridging clinical and business objectives, managing P&L, and guiding cross-functional teams across R&D, clinical operations, regulatory, medical affairs, commercial teams, and business development.• Scientific and medical leadership with a clear vision and drive• Leading Biomarker Strategies & Bioanalytical Assay Development Teams• Clinical Trials & Regulatory Strategy (Phases I–IV, BLA, Orphan/Breakthrough)• Strategic CRO Executive Leadership, Lab Partnerships, Technology Commercialization Executive-level business management skills using KPIs and P&L management • Spokesperson with extensive communication skills• Building High-Performing Teams• Strategic Partnerships• Business Development• M&A strategy• Regulatory compliance (CAP/CLIA/GCP/GLP)

Experience

1. Chief Scientific Officer

   VivoSim Labs, Inc.

   Nov 2025 — Present · San Diego, CA, US

   VivoSim Labs is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional human tissue models of liver and intestine. Dr. Sethi is leading the scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs). He is expanding the company’s biomarker and mechanistic insight capabilities, strengthening scientific governance for pharmaceutical sponsors, and collaborating closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems.

Education

• Københavns Universitet - University of Copenhagen

  Doctor of Medicine - MD

• Københavns Universitet - University of Copenhagen

  Doctor of Philosophy (PhD), Genetics of Hypertension, Ischemic Heart Disease, and Ischemic Cerebrovascular Disease