Staci J Kearney

About Staci J Kearney

As a biomedical professional with more than 10 years of experience, I have a passion for…

Experience

1. Founder & President

   Elevation Strategic Development, Llc

   Jan 2019 — Present

   Providing clinical, regulatory, and scientific consulting and services for the diagnostics, medical device and pharmaceutical industries Expertise in: • Product development and regulatory strategy for initial market entry and global expansion • Regulatory communication strategy and execution • Class II medical device (including diagnostic) development pathway and requirements • Design and timing of companion/complementary diagnostic development, such as: ­ - Patient selection for early and late phase clinical trials, including risk determination ­ - IDE and/or CLIA requirements and compliance ­ - Assay endpoint selection and validation design • Biomarker hypothesis development • IVD design and validation for codevelopment and stand-alone applications • Use of clinical trial assays to support pharmacodynamic endpoints • Vendor and clinical trial site selection for RUO/IUO IVD development and testing • Global development standards, guidelines, and regulations (eg, GCP, QSR, IVDR, ISO, ICH, CAP/CLIA) • Quality Management System design Services include: • Comprehensive and/or focused pharmaceutical and medical device pre- and postmarket development consulting • Medical writing and editing: study protocols, clinical reports, regulatory submissions/filings, etc • Regulatory communication support, including briefing package generation and responses to feedback ­ - Examples: Pre-Submission meetings, Risk Determination, Informational meetings, Type C meetings, Protocol Advice/Scientific Advice Requests • Review of validation plans, study protocols and reports, regulatory submissions, etc • Conduct PMCF studies, including generation of clinical investigation/study plans and reports • Clinical trial monitoring

Skills

• Protein Chemistry
• Molecular Biology
• Immunology
• Data Analysis
• Cell Biology
• Medical Devices
• Pharmaceutical Industry
• Commercialization
• Western Blotting
• Laboratory Skills
• Elisa
• Regulatory Affairs
• Polymerase Chain Reaction (Pcr)
• Pcr
• Life Sciences
• Laboratory
• Flow Cytometry
• Cell Culture