Castro

Director of Medical Affairs @QuidelOrtho

Raritan, NJ, US

Spearheaded medical affairs, aligning product lifecycle strategies with patient safety and efficacy standards.• Provide medical input and leadership in clinical data generation• Lead the team in defining key medical requirements for new product development and on-market assays• Manage Medical Affairs personnel to align deliverables required for conducting clinical studies• Assess benefit-risk and participate in risk management strategies• Map key trends of in vitro diagnostic for different disease states• Engages with customers and building relationships with KOLs• Attends society and medical conferences staying abreast of the latest scientific advancements to inform product development, clinical strategies, and evidence generation• Provide medical support and draft clinical protocols working closely with Clinical Affairs, Regulatory/ R&D/ Marketing/Product Development Team• Identify new products & solutions to meet unmet needs and to maintain competitivity• Generate additional clinical evidence by managing post-market studies & developing publications• Subject Matter Expert on IVDR regulatory compliance• Initiatives:o Conducted comprehensive gap assessments of existing processes, identifying key areas for improvement and successfully implementing streamlined workflows that enhanced efficiency and compliance across medical affairs operations. o Led the development and execution of evidence-based reports and documents through rigorous literature searches, ensuring alignment with regulatory standards and providing critical input to support new product development.o Increased organizational compliance by integrating scientifically accurate and up-to-date medical information into product development strategies, resulting in enhanced documentation and adherence to industry regulations.o Successfully implemented an AI-powered tool for conducting evidence based literature search and review that led to optimizing Medical Affairs workflow.

Northern Illinois University

Executive MBA

University of the East

Doctor of Medicine (M.D.), Medicine

Northern Illinois University

Master of Public Health (M.P.H.), Health Services Administration

University of Santo Tomas

Bachelor of Science (B.S.), Medical Technology