Developed and helped execute plans for expansion of Serosep into the US clinical marketProvided intelligence to senior company leadership regarding US testing and regulatory landscape

Led the creation and management of a team enabling integration of clinical, medical and scientific affairs functions. Identified key collaborators and developed pre-clinical and clinical study plans to introduce new products into target markets. Managed pre- and post-marketing studies in collaboration with partner companies. The effective design control process I designed in conjunction with regulatory affairs ensured our regulatory compliance with ISO 13485, ARTG, MDSAP, and CE-IVDD and prepared the company for CE-IVDR registration. My contributions included:• Design and execution of pivotal validation and verification studies for initial clearance of PlexPCR® SARS-CoV-2 and subsequent claims extension studies; completed projects on time and within budget.• Provision of key clinical expertise and direction to enable SpeeDx Research Innovations and Marketing Team members to formulate strategies for developing applications of novel SpeeDx technologies (PlexPlus™ and InSignia™).

I applied my communication, leadership, and organizational skills to synchronize post-launch marketing studies in Australia and Europe for CE-IVD and TGA cleared product lines. My team negotiated agreements with CROs to ensure continued pre-clinical and clinical testing support. Garnered strategic partnerships to grow the use of SpeeDx technology powered assays on IVD platforms.• Formulated roadmap for introducing SpeeDx products into U.S. market; generated exclusive agreement with LabCorp for provision of custom products for laboratory developed tests.• Created agreements with U.S. organizations to ensure supplies of clinical samples and reference materials for R&D work in Australian SpeeDx laboratories.

In this position, I l directed and mentored a team of research scientists to build novel diagnostic assays and testing strategies in microbiology, immunology, and infectious disease. Executed strategies for generating supplementary clinical trial data and publication pipeline to support use of molecular testing during diagnosis and management of vaginitis (NuSwab™ test) and led the team transferring these assays to a commercial platform. Championed the introduction of novel technologies into LabCorp, including Next Generation Sequencing for microbiome analysis, Nanotrap® technology for enhancing sensitivity of analyte detection in non-conventional matrices, and PlexPCR technology for superior multiplexing of LDTs.Was responsible for directing an operations team that successfully consolidated three molecular ID laboratories to create the largest molecular ID testing facility in the U.S which is now completing 70% of all LabCorp testing for HBV, HCV, and HIV-1.

Provided clinical and scientific leadership responsible for raising test volumes by up to 30% YOY which resulted in revenue growth from $65M to $120M. I envisioned the creation of a production-oriented molecular biology laboratory and brought it to fruition as a vertically integrated facility that operated at maximum efficiency. The activities I led resulted in 25+ laboratory sourced molecular assays that generated $3M in cost-of-goods savings.