Gabriela Campoy

About Gabriela Campoy

Nonclinical toxicologist with 14 years of experience providing scientific and regulatory leadership in animal health, study design and conduct, and global drug development programs. I specialize in designing and executing nonclinical safety studies and programs to support IND, IB, NDA, and post‑marketing submissions, ensuring GLP compliance and alignment with global health authority expectations.Grounded in my training as a veterinary clinical pathologist, I bring a uniquely holistic and mechanistic lens to toxicology. This background enhances my ability to interpret complex clinical pathology, pathology, and in‑life data, strengthen translatability across species, and identify meaningful biomarkers and safety signals early. My expertise spans toxicology study design, data interpretation, and authoring regulatory documentation across biologics, gene therapies, and small molecules. Combined with experience in hemato‑oncology research and regulated CRO study conduct, I deliver robust risk assessments and strategic, scientifically defensible recommendations.Recognized for high‑quality deliverables, effective CRO oversight, and partnering seamlessly with cross‑functional teams to address complex scientific and regulatory challenges. Skilled in preparing weight‑of‑evidence assessments, responding to regulatory queries, and representing clients in health authority interactions.Let’s connect to explore opportunities to advance innovative therapies through rigorous nonclinical safety evaluation and regulatory excellence.

Experience

1. Senior Toxicologist

   Toxalliance Llc

   Jun 2025 — Present · Seattle, WA, US

   Provides scientific and regulatory leadership in the development and execution of nonclinical programs to support global submissions. Oversees and critically reviews study protocols, expert reports, and regulatory documents (Pre-IND, IND, NDA [modules 2.4, 2.6.2, 2.6.4, 2.6.6], Type D, weight-of-evidence assessments), ensuring clarity, compliance, and strategic alignment with health authority expectations.Delivers high-level scientific input through detailed editorial review, constructive feedback, and comprehensive commentary on nonclinical documentation. Performs advanced data interpretation and visualization, including statistical analysis, tabulation, and graphical representation, to inform decision-making and regulatory strategy.Serves as a point of contact for regulatory and toxicology inquiries, providing guidance to clients. Supports study monitoring through on-site and remote participation, ensuring adherence to GLP standards, protocol integrity, and regulatory compliance.Contributes to operational excellence by coordinating CRO oversight, managing timelines, and ensuring quality deliverables for nonclinical safety studies across diverse modalities (small molecules, biologics, gene therapies) and indications (ophthalmology, neurology, autoimmune/inflammatory, oncology). Authors nonclinical sections of regulatory submissions and represents clients in health authority interactions, driving successful outcomes for investigational products across multiple therapeutic areas.

Education

• Centro Universitário de Jaguariúna - UniFAJ

  Graduate Diploma in Veterinary Clinical Pathology, Postgraduate program with thesis

  2013

• Michigan State University

  Master's degree, Pharmacology and Toxicology

  2025

• Universidade Estadual Paulista Júlio de Mesquita Filho

  Degree in Veterinary Medicine, Veterinary Medicine

  2011

Skills

• Clinical Pathology
• Veterinary Pathology
• Virtual Assistance
• Cytopathology
• Hematology
• Veterinary
• Laboratory Skills
• Bone Marrow
• Proteção Animal
• Science
• Hematologia
• Veterinary Medicine
• Inglês
• Veterinária
• Bioquímica
• Animal Nutrition
• Cytology
• Medicina Veterinária