Sarah Harris

About Sarah Harris

Highly accomplished translational medicine expert with twenty years of global experience in preclinical though post-marketing TM strategy development and implementation, bioanalytical development, global regulatory filings, lab, site and P&L management and due diligence. Experience in a variety of organizational types including pharma, biotech, CRO, start-up, and nonprofit. Therapeutic area expertise in neurology, oncology, vaccines, immunology and immuno-oncology. Proficiency with modalities including monoclonal antibodies, gene therapy, stem cell therapy, ADCs, bispecifics, small molecules, recombinant proteins, antisense therapy and radioimmunotherapy. Support of multiple marketed compounds including Prevnar 13, Rituxan, Zevalin, Tysabri and Zeposia. Core competencies: Translational Medicine (TM) strategy development and implementation for preclinical, clinical and post-marketing programs. Due diligence (determine scientific merits of research and clinical programs) to support in-licensing of compounds and acquisition of biotech companies. Biomarker, PK and ADA assay development and validation Initiation and management of Key Opinion Leader (KOL) programs in academic institutions to further translational research goals. Drafting of regulatory documents including IND, NDA and BLA packages. Frequent interactions with global regulatory agencies including FDA, MHRA, PMDA, EMA etc Timeline and budget management of numerous simultaneous research and development programs. Drafting and presentation of scientific data internally and externally. Contract Research Organization (CRO) management. Global clinical development.

Experience

1. Head, Immunology, Cardiovascular and Neuroscience Translational Development

   Bristol Myers Squibb

   Mar 2025 — Present · San Diego, CA, US

   Lead the translational development disease teams for immunology, cardiovascular and neuroscience TAs

Education

• West Virginia University

  BA, Chemistry

• West Virginia University

  BA, Biology

• University of Rochester School of Medicine and Dentistry

  PhD, Immunology

  1995 — 2001

Skills

• Drug Development
• Biopharmaceuticals
• Lifesciences
• Glp
• Oncology
• Flow Cytometry
• Biomarkers
• Life Sciences
• Antibodies
• Elisa
• Protein Chemistry
• Biotechnology
• Immunology
• Assay Development
• Molecular Biology
• Immunoassays
• Pharmaceutical Industry
• Drug Discovery
• Clinical Development