Hui-Jing Yu

About Hui-Jing Yu

As a strategic clinical development leader with over 15 years of experience in neuroscience, imaging, and biomarker-driven innovation, I thrive at the intersection of science, strategy, and patient impact. My expertise spans the design and execution of complex clinical trials (Phase I-IV), regulatory strategy, and translational medicine, with a strong track record of advancing therapies for neurodegenerative diseases, Alzheimer’s, Parkinson’s, and other CNS disorders.I am passionate about transforming scientific discoveries into real-world treatments through cross-functional leadership, regulatory engagement, and innovative biomarker integration. My approach is flexible, data-driven, and patient-centric, ensuring that clinical development aligns with evolving regulatory landscapes and therapeutic needs. I am always open to exploring collaborations, scientific discussions, and leadership opportunities that align with my mission to advance neuroscience and medical innovation. Let’s connect and explore how we can shape the future of drug development together!

Experience

1. Director, Clinical Science

   Alnylam Pharmaceuticals

   Jul 2025 — Present · Cambridge, MA, US

   Serve as a Director, Clinical Science in the CNS therapeutic area at Alnylam Pharmaceuticals, leading the scientific and operational strategy of RNAi-based clinical development programs from early to late stage. I collaborate cross-functionally with physicians, regulatory, clinical operations, and biomarker teams to ensure rigorous, high-quality execution of clinical trials aimed at transforming treatment for neurological disorders.Key responsibilities include:• Designing and executing global clinical development plans (CDP), including study protocols, INDs, NDAs, and regulatory strategy• Serving as a clinical science lead for trial design, data interpretation, and study execution• Supporting interactions with global regulatory agencies and contributing to health authority correspondence• Driving endpoint strategy, including biomarker, imaging, and patient-reported outcomes to support clinical and regulatory goals• Contributing to internal governance and external communications, including advisory boards, investigator meetings, and scientific conferences• Acting as a cross-functional influencer in translational strategy and target feasibility assessments in partnership with research

Education

• Stony Brook University

  Doctor of Philosophy (Ph.D.), Master's Degree, Biomedical Engineering | Radiology | Neurology | Physiology and Biophysics

  2007 — 2011

• Stony Brook University

  Bachelor’s Degree, Biomedical Engineering | Electrical Engineering

  2001 — 2005

Skills

• Medical Affairs
• CRO
• R&D
• Tissue Engineering
• Image Processing
• Medical Devices
• Clinical Research
• Dxa
• Project Management
• Rare Diseases
• Clinical Trials
• Big Data
• Biotechnology
• Cardiac Electrophysiology
• Medical Imaging
• Statistical Analysis Plans
• Mri
• Pharmaceutical Industry
• Fda
• Animal Models
• Liver Disease
• Translational Research
• Cell Culture
• Signal Processing
• Diabetes
• Biomedical Engineering
• Respiratory Disease
• Clinical Development
• Neuroscience
• Biomarkers
• Medical Writing