Javier Gonzalez

About Javier Gonzalez

Medical Director and Global Safety Lead at Takeda with 20+ years of clinical experience and 5+ years in pharmaceutical safety and drug development.As a board-certified neurologist and neuro-oncologist, I led multidisciplinary brain tumor and multiple sclerosis programs before transitioning to industry. Today I serve as Global Safety Lead for investigational compounds in hematology.My pharma experience spans solid tumor oncology, neuro-immunology, neuro-oncology, and hematology.Areas of focus:• Signal detection, validation, and benefit-risk assessment across all stages of development (FIH through post-marketing)• NDA/sNDA/IND submissions and FDA/EMA regulatory interactions• Chairing Global Safety Teams and Safety Management Teams• DSUR/PSUR/PADER authoring and Investigator\'s Brochure maintenance• Labeling strategy — Target Label Profiles, Global Labeling Committee• Applied AI in pharmacovigilance — deterministic Python pipelines for TEAE tables, SAE narratives, laboratory shift analyses; M365 Copilot Studio agents for GST workflowsBefore industry, I co-directed neuro-oncology fellowship programs at Ohio State and the NCI, established West Virginia\'s only multidisciplinary brain tumor and multiple sclerosis programs.Open to discussions on pharmacovigilance strategy, clinical development, and AI applications in drug safety.

Experience

1. Global Safety Lead

   Takeda Oncology

   Jun 2025 — Present · Orlando, FL, US

   Lead safety contributions for major regulatory submissions in hematology/oncology, including safety narrative development, aggregate analyses, and labeling recommendations.Chair cross-functional safety governance forums, overseeing signal identification, validation, assessment, and escalation across clinical development programs.Deliver integrated safety analyses across multiple domains, including TEAE profiling, serious adverse event evaluation, laboratory shift analysis, and cardiovascular safety assessment.Maintain core safety documents, including Investigator\'s Brochure safety sections and annual aggregate safety reports in accordance with ICH guidelines.Contribute to label development through Target Label Profile design and participation in cross-functional labeling committees.Oversee end-to-end pharmacovigilance analysis workflows from clinical data intake through regulatory-grade deliverables, with rigorous audit and traceability standards.Coordinate responses to health authority inquiries on trial design, inclusion/exclusion criteria, and safety monitoring plans.Build and deploy AI-enabled pharmacovigilance tools, including automated pipelines for safety report generation that streamline recurring analyses across safety review cycles.Design and implement agentic workflows using M365 Copilot Studio and Power Automate to automate data extraction and safety surveillance processes.

Education

• Universidad del Rosario

  Doctor of Medicine (M.D.), Medicine

  1992 — 1997

• Fundación Universitaria de Ciencias de la Salud

  Neurologist, Neurology

  1999 — 2003

• The University of Texas MD Anderson Cancer Center

  Fellowship, Neuro-oncology

  2004 — 2006

• The University of Texas Medical Branch

  Neurology

  2006 — 2010

Skills

• Board Certified
• Healthcare Management
• Research
• Oncology
• Neuro-Oncology
• Hospitals
• Medical Research
• Healthcare
• Clinical Development
• Neuroscience
• Neurology
• Clinical Trials
• Clinical Research
• Treatment
• Medicine
• Public Health
• Medical Education
• Cancer
• Multiple Sclerosis
• Clinical Decision Support