Scientific Associate Director

William D. Weber Dartmouth, MA 02748 | 774-404-0398 | [email protected] |william-weber-03113027 Associate Scientific Director Pharmaceutical leader with experience advancing biomarker and digital pathology solutions to accelerate drug discovery, translational science, and clinical development. Recognized subject matter expert in pathology and technology, with proven success developing and validating fit-for-purpose clinical biomarkers, implementing GxP-compliant digital pathology platforms, and driving regulatory alignment across global programs. Adept at cross-functional collaboration, vendor and CRO management, and integration of emerging technologies to enable actionable insights, inform therapeutic decision-making, and address unmet patient needs across complex, multi-organ diseases. Core Competencies Biomarker Strategy & Development | Digital Pathology Platforms | Translational Science | Clinical Biomarker Validation | Regulatory Documentation & Compliance (IVDR, GxP) | CRO & Vendor Management | Histopathology Expertise | Spatial Biology & Single-Cell Technologies | AI/ML Image Analysis | Cross-Functional Collaboration Laboratory Medicine | Process Optimization & Standardization | Stakeholder Engagement | Drug Discovery & Clinical Development Integration Professional Experience Takeda Pharmaceuticals, Cambridge, MA 2021 – Present Associate Scientific Director, Biomarker Science and Technologies (BST) Lead the development, validation, and regulatory alignment of fit-for-purpose biomarker and digital pathology solutions while integrating advanced platforms, managing CROs, and driving cross-functional collaboration to enable clinical decision-making and enterprise-scale implementation. • Pathology and technology Subject Matter Expert (SME), establishing technical standards for developing and validating fit-for-purpose biomarker and digital pathology assays for clinical endpoints. • Work closely with global regulatory groups to support biomarker/histology documents: pathology reading plans, SMP, BAP, DTA, CLR, CRS and ICF documents. • Manage CRO’s and develop histology charters, histology protocols, lab manuals, pathology reading plans, pathology concordance, glass vs digital validation and image transfer solutions to support clinical trials. • Assess clinical fit-for-purpose technologies and assays from drug discovery into translational science for clinical histopathology endpoints. • Generate business justification, work with key stakeholders across IT, QRA and validation/testing to integrate and validate a GxP-compliant digital pathology platform as an enterprise system solution for managing images and metadata for pre-clinical and clinical studies. • Enhance digital pathology platforms by integrating image analysis tools, connecting to clinical LIMs systems, and automating metadata pipelines for multi-omics deep analysis. • Develop best practices for image QC, IHC and in situ optimization, spatial biology assessments, and AI/ML/DL applications. • Educate colleagues and groups by providing internal white papers and presentations around slide-based biomarker technologies to understand complex technologies and how it increases our understanding of clinical studies. • Develop cross-functional working groups to identify synergies and pinch points across workstreams and work towards harmonizing efforts for standardization. • Ensure IVDR compliance across CRO digital pathology workflows for downstream digital pathology reads. • Access existing and new single cell spatial transcriptomic technologies and evaluate clinical fit for use, generate guidance documents and white papers. William D. Weber [email protected] Page 2 • Support program leaders providing histopathology guidance developing effective SOWs for outsourcing, provide technical assessments of vendors ability to perform complex assays, manage data transfer, interpretation, and quality. • Develop GxP SOP’s across the digital pathology workstream to; upload, build architecture within image management platform and develop minimum data requirements and ontology for metadata for automated upload with digitized images. • Certification digital pathology 2021. Sanofi-Genzyme, Framingham, Ma 2017 – 2021 Principal Scientist-Lab Head Preclinical Translational Science • Supported therapeutic modalities; small molecules, biologics and AAV programs in accessing animal studies, human target credentialing and off-target assessments using mIMF, in situ hybridization and digital pathology (QIA). • Expanded innovative molecular pathology platform to support therapeutic business units; gene therapy, oncology, neuroscience, inflammation, rare disease and gastroenterology to deliver high impact data packages. • Developed vendor deliverables, manage timelines and outsourcing by developing effective SOW’s, educate customers around expectations, interpret data and develop vendor capabilities. • Enhanced and harmonize global pathology groups to identify syner