Open to opportunities

Daniella Bianchi Frias, PhD

@daniellabianchifrias

Message

Clinical and translational scientist specializing in oncology diagnostics and evidence generation.

United States

Message

What I'm looking for

I seek roles leading translational evidence programs and assay validation within collaborative, cross-functional teams that drive regulatory approvals and clinical adoption.

I am a strategic clinical and translational scientist with a Ph.D. in Molecular & Cellular Biology focused on oncology diagnostics and evidence generation.

I have led multidisciplinary programs integrating clinicians, bioinformaticians, and technical experts to develop and validate NGS, ddPCR, and methylation-based assays that supported FDA PMA approval.

I directed end-to-end validation and regulatory strategy for liquid biopsy companion diagnostics, reduced sample procurement costs by over $1M, and authored regulatory submissions, technical documentation, and peer-reviewed publications.

I mentor and supervise junior scientists, collaborate cross-functionally to translate complex data into clinical impact, and apply real-world evidence and advanced molecular technologies to accelerate diagnostic adoption and improve patient care.

Experience

Work history, roles, and key accomplishments

Scientist II, IVD Assay Development

Resolution Bioscience

Feb 2021 - Dec 2024 (3 years 10 months)

Led evidence generation and regulatory strategy for FDA approval of NGS-based cfDNA liquid biopsy companion diagnostics, authored analytical validation for PMA submission, and reduced sample acquisition costs by over $1M while accelerating timelines.

NGS Regulatory Submissions Bioinformatics

Scientist I, R&D

Ambry Genetics

Jan 2019 - Jan 2021 (2 years)

Scientific lead for development and validation of NGS, ddPCR, and DNA methylation assays supporting oncology biomarker discovery and clinical utility; implemented ddPCR system and contributed to patent application.

NGS DdPCR Methylation SOPs Technical Writing Cross Functional Collaboration Training

Staff Scientist

Fred Hutch

Jan 2015 - Dec 2018 (3 years 11 months)

Directed translational research generating clinical evidence for non-invasive prostate cancer biomarkers, coordinated specimen collection and IRB protocols, and collaborated with statisticians and bioinformaticians to produce peer-reviewed publications.

Biomarker Discovery Urine RNA Assays Statistical Analysis Team Leadership

Postdoctoral Research Fellow

Fred Hutch

Jan 2010 - Dec 2015 (5 years 11 months)

Designed and executed evidence-generation projects including urine RNA-based assays and multiplex gene expression panels for prostate cancer risk stratification, resulting in first-author publications and trainee supervision.

Urine RNA Assays Gene Expression Panels Experimental Design Mentorship Data Analysis

Education

Degrees, certifications, and relevant coursework

University of Washington / Fred Hutch

Doctor of Philosophy, Molecular and Cellular Biology

Ph.D. in Molecular and Cellular Biology; dissertation on natural variation in mouse prostate and the influence of the aged prostate microenvironment in prostate cancer.