Jason Wall

About Jason Wall

Experienced Translational Science Leader with over 15 years of experience studying tumor biology, the tumor microenvironment, and the immune system. Experienced in biomarker strategy development supported by assay development and validation, applied against oncology and inflammation pre-clinical and clinical goals. Advanced studies in pre-clinical settings through registrational trials, including interactions with the FDA, EMA, and PMDA across multiple modalities such as immune-oncology modulators, antibody drug therapeutics, small and large molecule inhibitors and engineered cell therapies. Key Skills Experienced in assay development and validation applied both internally and outsourced with CROs- Multiplexed methods for characterizing complex immune subsets in peripheral blood, bone marrow, and the tumor micro-environment in tissue biopsies- Assessment of soluble factors (e.g. cytokines, or soluble target) using plate-based assays. Deep understanding of intracellular and apoptotic signaling, molecular biology, and proteomic applications. Assay applications spanning execution in clinical studies through in vitro, ex vivo and in vivo models. Team leadership through direct and indirect reports as well as working though complex organizational matrices. Selected Achievements Developed and validated fit-for-purpose biomarker assays supporting pre-clinical and clinical endpoints. Provided analysis that guided clinical trial decisions, patent and IND filing, and registrational submissions. Implemented biomarker strategy and assay application across solid tumor and hematologic indications (Multiple myeloma, NHL [DLBCL, CLL, MCL, FL], ALL, bladder, lung, head and neck, sarcoma, and breast cancer) Authored CSRs, supplemental reports, CTD summary documents, and responses to Health Authority queries, supporting successful drug approvals with multiple regulatory agencies.

Experience

1. Associate Director, Scientific Writing

   Bristol Myers Squibb

   Mar 2024 — Present · Seattle, WA, US

   Lead document strategy development and authoring of regulatory documents in support of submissions and approvals in key markets and world wide geographies. Provide support for fit-for-purpose regulatory documents (clinical pharmacology, clinical study reports, safety reports) to facilitate communication of information during development, submission, approval, and life cycle management of products in BMS pipeline.

Education

• California State University, Fresno

  Bachelor of Science (B.S.), Biology

• San Diego State University

  Doctor of Philosophy (Ph.D.), Cell and Molecular Biology

  2000 — 2005

• UC San Diego

  Doctor of Philosophy (Ph.D.)

  2000 — 2005

Skills

• Technology Transfer
• Validation
• Oncology
• Fluorescence Microscopy
• Immunohistochemistry
• Multiple Myeloma
• Elisa
• Assay Development
• Immune Oncology
• Immunofluorescence
• Ind
• Small Molecules
• Registrational Trials
• Biomarker Development
• Cancer
• Cell Biology
• Biopharmaceuticals
• Translational Science
• Translational Research
• Biomarker Discovery
• Dna Extraction
• Multiplexed Fluorescent Tissue Imaging
• Clinical Development
• Clinical Trials
• Molecular Biology
• Cell Culture
• Western Blotting
• Biomarkers
• Multi-Color Flow Cytometry
• Pcr
• Biotechnology
• Team Leadership
• Rna Isolation
• Immunology
• Proteomics
• Technical Presentations
• Clinical Research
• Breakthrough Designation
• Antibody Drug Conjugate
• Drug Development