Kristina Dziki

Product #1 (in development): Next Generation Lung Cancer Screening in vitro diagnostic (IVD) test (May 2025 - present)

• Led a cross-functional core team to develop and validate the entire product, generating data for FDA Premarket Approval (PMA) submission.
• Drove two technical subteams (Software & Data, Assay) to develop and validate machine learning features, classifiers, and models; software pipeline; and wet lab assay for cancer detection using patient plasma samples
• Managed alliances with strategic collaborators and vendors.
• Partnered with functional leads (across science, engineering, medical, regulatory, business) to enable strategic, trade-off decision-making, and prioritization during phase gates/stage gates.

Product #2 (on market): Cancer monitoring research assay (Jan 2024 - Jun 2025)

• Led a cross-functional core team to develop and commercialize DELFI-Tumor Fraction, a research assay for pharmaceutical and biotechnology companies to use in Phase 1 oncology drug development trials as a tool to identify early evidence of treatment efficacy.
• Supported business development and commercial teams in driving revenue-bearing collaborations
• Drove creation and review of technical marketing materials

New Product Development (Jan 2022 - Jun 2025)

• Led cross-functional teams to define new product concepts (via lean canvas), business cases, target product profiles (TPP), user needs
• Created product development roadmaps (covering phases of feasibility, development, analytical validation, clinical validation, and launch).

Research Portfolio (Translational Science and Genomic Science) (Jan 2022 - Jun 2025)

• Managed a portfolio of cancer research studies (treatment monitoring, screening, subtyping).
• Drove prioritization, planning, and management of a multi-year, multi-million dollar research budget.
• Supported technical leads with project execution, risk mitigation, and communication (with internal and external collaborators in academia/industry).

Public health and biomedical research projects for various sponsors (HHS, Military, JHU, etc.)

• Data analysis for COVID-19 pandemic response health resource allocation (e.g., staff, supplies, therapeutics).
• Implementation of a virtual clinic for Navy Corpsmen.
• Operationalization of a clinical research study (NCT04820387), collecting data with both novel, non-contact sensors and medical-grade sensors, with the goal of prototyping an integrated sensor platform that extracts vital signs and predicts health status for potential remote monitoring, telemedicine, and clinical applications.

Software product management and testing on agile software modernization programs for Federal clients (FDA Center for Biologics Evaluation & Research and Department of Treasury)

• Translated business needs into technical requirements for software developers and user experience (UX) designers.
• Front-end and back-end testing of the final product.
• Consulted pro bono for ARMR Systems, a medical device startup.