Castro
Director of Medical Affairs, Executive MBA
- Role
- Director of Medical Affairs at QuidelOrtho
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Castro
Seasoned Medical Professional with extensive experience in pharmaceutical clinical…
Experience
Director of Medical Affairs
Jan 2023 — Present · 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.
Education
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
2014 — 2017
University of Santo Tomas
Bachelor of Science (B.S.), Medical Technology
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