Baijun Kou
Pathologist (PHCS CDx Development Qualified Reader) @ Roche
About
Pathologist and scientist with extensive expertise in biomarker discovery, diagnostic agent development, and research. Skilled in integrating clinical medicine with biology to drive advancements in disease therapy. Proven experience in anatomic pathology, digital pathology, and imaging analysis to support preclinical to phase III clinical studies. Recognized for developing and validating biomarkers and tools that support precision medicine. Key Skills: • Pathology Expertise: Pathology slide reading, interpretation and disease characterization • Biomarker Research: Identification, characterization, validation, prevalence analysis and application in clinical specimen assessment • Clinical Research: Expertise in molecular pathology and tissue-based research methodologies • Disease Focus: Oncology &immune-oncology, infectious disease, autoimmune and metabolism disease. • Clinical Trial Experience: Experience from pre-clinical, first in human to Phase III clinical trials in study design, patient population selection, protocol drafting, data analysis and safety evaluation • Project Management: Lead projects across function teams, ensuring timely and within-budget completion with high quality • Data Analytics: Utilizing multi-AI based software for data analysis and interpretation
United States
Tucson
Biotechnology
Clinical Trials protocol drafting, Clinical Monitoring, Standard Operating Procedure (SOP), Clinical Data Management, Electronic Data Capture (EDC), Regulatory Submissions, Data Management, Clinical Trials, Digital Pathology application, Biomarker IHC validation, Histopathology, Cancer Research, Biomarker development and characterization , Cell Biology, Molecular Biology, Immunology, Project Management, Database Design, Good Clinical Practice (GCP), Machine Learning
Experience

Senior Principal Scientist (Pathologist/ Clinical Scientist)
New York, United States
• Interpreted clinical samples for diagnostic purposes, providing detailed histological characterizations and biomarker quantification to determine clinical enrollment criteria, drug efficacy phenotype and prediction of ORR/recurrence rate for study protocol development • Led validation of immunohistochemistry (IHC) assays for biomarkers development to support various companywide programs, including IO-Bispecific, ADC, Car-T, autoimmune and metabolism drug development and for target CDx development • Collaborated with research, translational and clinical teams to align priorities, delivering expertise in biomarker validation, indications prevalence analysis, and digital multiplex data analysis (IHC, multi-IHC, IF, ISH) in both animal model and patient specimen • Conducted extensive literature search, performed competitive landscape analysis, engaged with KOLs for the identification of novel targets and clinical development strategy plan • Established a novel clinical biomarker validation and development platforms to serve cross-functional teams from pre-clinical IPA, First-in-Human studies through Phase II clinical trials • Developed clinical pharmacology assessment strategy for Phase II/III study and performed data analysis to support pre-market application • Characterized and annotated H&E samples for genomic analysis, scRNAseq, proteomics analysis and integrated data to determine biomarker development plan • Collaborated with clinical team for patient monitor analysis and provided interpretation for drug safety evaluation and AE prevention • Participated and presented data at scientific advisory boards to support program, be responsible for selection and delivery of pharmacodynamic and biomarker assays • Provided scientific rationale and pathological evaluation in the innovative design, execution, and data interpretation of clinical studies to support IND, NDA filling and labelling for FDA approval

Staff Scientist (Clinical Scientist)
Texas Children's Hospital-Baylor College of Medicine
Houston, Texas Area
• Reviewed research proposals, offering pathological expertise for biomarker focused projects to ensure scientific rigor and alignment with study goals • Employed RNA scope (ISH) and laser capture microdissection (LCM) techniques for RNA expression, single-cell RNA sequencing and Mass-Spec analysis • Leveraged multiple web-based tools to analyze TCGA datasets and inform biomarker target selection • Collaborated with computer scientists to drive advancements in digital pathology research and data analysis • Evaluated immuno-checkpoint biomarkers and conducted IHC imaging data analysis, supporting patient selection strategies for immune-oncology clinical trials • Provided pathology expertise in selecting research cases for immunotherapy and targeted therapy studies

Staff Scientist(Clinical Scientist)
• Utilized molecular and cellular biology techniques for biomarker development across multiple projects involving human and animal subjects, contributing to cross-institutional research efforts • Developed and optimized new antibody-based assays for disease characterization • Developed multiplex IHC methodologies and applied machine learning algorithms to improve imaging data analysis accuracy • Served as a research pathologist, analyzed H&E slides from patient samples to support the cancer center’s tissue bank and advance research initiatives • Designed research proposals for tissue-based clinical studies and built productive collaborations with clinicians • Collaborated with CRAs to monitor patient outcomes and evaluate targeted therapy effects and safety vigilance • Created a research database for data management and used a range of software packages for comprehensive data analysis • Engaged with industry partners for pathology-related collaborations, expanding external partnerships • Prepared presentations, authored research papers, and contributed to funding applications • Supervised junior staff and managed the research budget, ensuring effective resource allocation and team development.

Pathologist(Clinical program manager)
London, United Kingdom
• Led histopathology and molecular pathology initiatives to support all R&D projects to support PET/ SPECT/CT/MRI/Ultrasound scan agent development for disease detection and therapeutic monitoring • Conducted biomarker identification, antibody selection and validation, and imaging data analysis for both pre-clinical and clinical studies • Led multiple research projects within a matrix team, from Proof of Mechanism (PoM) stages through clinical Phase II trials • Developed SOP for histology and pharmacology study and selected CROs to conduct these studies • Analyzed pathology and pharmacology study data, prepared technical reports, and presented findings to stakeholders for informed decision-making • Conducted scientific background analyses to assess project feasibility for IRB review and facilitate FDA and EMEA applications • Designed new projects and reviewed existing projects to support clinical operations and research process • Collaborated with global project management teams to meet project milestones on time and within budget, partnered with preclinical and clinical teams to accomplish study objectives • Assessed pre-clinical data and prepared essential documents for IND applications • Developed patient enrollment criteria and drafted clinical trial protocols, including ICFs and IB; conducted data review and analysis, Drafted clinical study report • Built partnerships with academic institutions for external collaborations and facilitated technology transfer

Clinical Research Scientist
Sheffield, United Kingdom
• Conducted research to investigate and identify biomarkers for early cancer detection and cancer progression • Characterized biomarkers and their pathways via molecular and cellular biology techniques, alongside animal models, to deepen understanding of cancer mechanisms • Designed biomarker clinical research projects and prepared pathology study protocols • Collaborated with clinicians to implement studies and classify specimens in adherence to ICH-GCP guidelines and clinical diagnostic standards • Validated selected biomarkers and performed IHC staining on clinical specimens, supporting reliable biomarker assessment and study accuracy • Managed high-throughput digital scanning and data archiving of slides using the Aperio system, streamlining data collection and accessibility • Established pathological analysis criteria and conducted comprehensive reading and scoring of slides to ensure consistent and accurate evaluation • Supervised Master’s and Ph.D. students in conducting research projects, fostering academic growth and contributing to research outcome • Prepared and delivered presentations, reports, and research papers, sharing findings at national and international conferences
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