Product Development Champion

I am a Product Development Champion with extensive experience in regulatory strategy, toxicology, biocompatibility, and safety assessment for medical devices, combination products, and pharmaceuticals. My work focuses on developing scientifically defensible safety positions that support regulatory submissions, clinical development, program advancement, and informed decision-making. I bring a practical, evidence-based perspective to helping teams translate complex toxicology, nonclinical, and clinical information into clear regulatory strategy.

I am a proud native of Raleigh, North Carolina, and I earned both my BS and PhD in Chemistry from North Carolina State University. My graduate research used computational density functional theory to study low-symmetry solid-state materials, which provided a strong foundation in analytical thinking, mechanistic interpretation, and complex scientific problem-solving. Over time, my career evolved from materials chemistry into regulatory toxicology, a professional path I sometimes describe as moving “from magnetism to mutagenicity.”

Over the past decade, I have led and supported nonclinical and biocompatibility strategies across pre-IND, IND, and 510(k) programs. My experience includes authoring and reviewing eCTD Module 4 nonclinical content, biocompatibility evaluations, toxicological risk assessments, health-based exposure limits, dose-selection rationales, and FDA-facing safety justifications. I have also overseen GLP and non-GLP toxicology programs, supported CRO engagements, and contributed to regulatory gap assessments and submission-readiness activities.

My subject matter expertise includes ISO 10993 and ISO 18562 biocompatibility frameworks; ICH Q3A, Q3B, Q3C, and M7 impurity and mutagenicity assessments; genotoxicity evaluation using computational toxicology tools; PK/PD interpretation; and nonclinical study design. In 2024, I became a Diplomate of the American Board of Toxicology (DABT), reflecting my commitment to scientific rigor, professional excellence, and continued growth in the field.

I am passionate about using regulatory science to help advance safe, effective, and innovative healthcare products. Outside of work, I enjoy hobbies that keep me creative, curious, and hands-on, including videography, photography, thrifting, origami, terrariums, small-scale modeling, LEGOs, video games, and science fiction. I am also drawn to technical projects involving Arduino builds, soldering, Python coding, Linux systems, web-based tools, and practical scripts that make work more efficient. In general, I enjoy tinkering, experimenting, and building things, which means it is probably best not to leave me alone with a screwdriver and too much free time.