Timothy Blicharz

About Timothy Blicharz

I am a versatile and enthusiastic diagnostics strategist with a proven track record of fulfilling corporate clinical, regulatory, quality, research, product development, and business objectives in fast-paced startup environments and large global organizations. I leverage my technical background to build cross-functional bridges within an organization, identify and mitigate risks, improve efficiencies during new product development, obtain product clearances and approvals, and represent the business through interactions with regulators, customers, and key opinion leaders.My key areas of expertise:• Clinical and Regulatory strategy: 510(k), EUA, PMA, international registrations, key opinion leader relationships, risk identification and mitigation• New product development: establishing cross-functional interfaces, product development strategy and leadership• Team building: recruiting and fostering high-performing teams, mentoring and empowering individuals to develop and execute high-priority projects• Scientific writing: FDA submissions, publications, clinical protocols, informed consent forms, grant applications• Public speaking: FDA meetings, conferences, trade shows, board of director meetings, investor discussions, customer onboarding, KOL and business development meetings• Project management: managing teams and peer-to-peer, developing budgets, timelines, and Gantt charts• Clinical study planning and execution: IRB submission, site selection, CRO management, internal and externally managed studies, usability and human factors with healthcare professionals and lay users• Broad technical knowledge base: point-of-care testing, at-home testing, central laboratory diagnostics, IVD product development, developing world diagnostics, over-the-counter devices, companion diagnostics, immunoassays, antibody microarrays, microfluidics, infectious disease testing, blood specimen collection and analysis, molecular diagnostics, biosensors, fluorescence microscopy, spectroscopy, cell-based assays, biomarkers, mechanical engineering, document management, quality systems

Experience

1. Senior Director of Clinical Research

   Delve Bio

   Dec 2023 — Present

Education

• Tufts University

  Ph.D., Chemistry

  2003 — 2009

• College of the Holy Cross

  BA, Chemistry

  1999 — 2003