Joseph Gyedu

About Joseph Gyedu

With over three years of experience in clinical research, including my current role at Sanofi, I bring a strong foundation in trial management, operational execution, and cross-functional collaboration across oncology and rare disease studies. I’ve contributed to improving patient enrollment, strengthening site relationships, and helping teams translate scientific objectives into clear, actionable operational plans.My background in Biomedical Sciences and specialized bench research enables me to communicate complex trial protocols, interpret data with precision, and support informed decision-making throughout the study lifecycle. I’ve trained study teams, supported process improvements, and ensured consistent adherence to IRB, FDA, and internal quality standards while partnering closely with global stakeholders on studies conducted worldwide.I am increasingly focused on the strategic side of clinical research, including market intelligence, technology evaluation, and the early identification of operational risks—areas that help cross-functional partners anticipate challenges and maintain study momentum. I am particularly interested in how AI and emerging technologies can enhance study design, strengthen data interpretation, and inform decisions across the drug development process.I am committed to advancing meaningful research, improving patient outcomes, and contributing to innovative approaches that elevate both clinical operations and the broader drug development landscape.

Experience

1. Associate Clinical Operations Study Country Lead, Rare Disease & Rare Blood Disorders

   Sanofi

   Dec 2024 — Present · Miami, FL, US

   Support U.S. site operations for global Phase rare-disease trials, including Lumina-3 (BTKi), LIBRA (BTKi), and BrAAVe (gene therapy) within the Clinical Study Unit (CSU), partnering closely with global study teams to ensure aligned planning, start-up, and execution across regions-Support site activation activities including Critical Document Package (CDP) management, ICF review, regulatory tracking, and readiness checks to enable timely First Patient First Visit (FPFV)-Present study design, protocol rationale, and inclusion/exclusion criteria at Site Initiation Visits (SIVs) and Site Qualification Visits (SQVs) to strengthen site alignment and improve screening accuracy-Serve as a key liaison to investigators, site staff, CRAs, CPAs, CRO partners, and cross-functional global teams, providing direction, resolving operational issues, and reinforcing strong site engagement-Support enrollment strategy, operational risk mitigation, and vendor oversight to maintain high-quality, inspection-ready study delivery across diverse therapeutic areas-Leverage AI-driven tools to optimize feasibility insights, identify operational bottlenecks, and support data-informed decision-making across CSU studies-Identify new use cases for AI within clinical operations and present recommendations to CSU leadership, introducing more efficient workflows and enhanced decision-support approaches.

Education

• University of Miami

  Master of Science - MS

• University of Miami

  Bachelor of Science - BS