Beth Chang Email & Phone Number

Seasoned leader in clinical development/ medical affairs, translational medicine and innovative diagnostics with 15 years in the biotechnology and pharmaceutical industries. Specializing in oncology, neurology, metabolic diseases, and companion diagnostics, with a strong track record of leveraging artificial intelligence and machine learning (AI/ML) to advance therapeutic and diagnostic biomarker development from IND/CTA through clinical proof-of-concept and planned regulatory submissions (NDA/BLA). Proven success in building and leading high-performing teams in translational medicine and companion diagnostics, designing strategic approaches to generate proof-of-mechanism evidence, and shaping program direction through collaboration with stakeholders across preclinical, clinical, regulatory, and computational AI/ML domains.Skilled in integrating AI/ML technologies with laboratory and digital biomarkers to accelerate clinical trials and improve patient outcomes. Well-versed in regulations and guidelines governing therapeutic (IND/CTA), diagnostic, and device (510K/PMA) development, with expertise in Good Clinical Practice (GCP) and comprehensive clinical trial design and execution. Strong understanding of the patient journey, clinical pharmacology, biostatistics, and clinical operations. Recognized for exceptional communication and leadership abilities, with a proven ability to inspire diverse teams and drive cross-functional collaboration. Committed to advancing patient care by seamlessly merging cutting-edge technologies with translational science.

Listed skills include Molecular Biology, Protein Chemistry, Oncology, Clinical Development, and 28 others.