Kelly Hall

About Kelly Hall

I am a clinical development leader with 13 years experience dedicated exclusively to ophthalmology research and innovation. Over the course of my career, I have contributed to more than 30 FDA-monitored trials, progressing from site-level coordination to director-level leadership across clinical operations, medical affairs, and strategic program management. I currently serve as Director of Clinical Development Operations at Aurion Biotech, where I help drive the advancement of first-in-class human corneal endothelial cell therapy. In this role, I focus on aligning trial execution, regulatory strategy, and cross-functional collaboration to ensure innovative science translates into meaningful patient outcomes. Previously at Orasis Pharmaceuticals, I played a key role in guiding the presbyopia program from End of Phase 2 FDA discussions through Phase 3 development and NDA submission, culminating in the FDA approval and commercial launch of QLOSI (CSF-1). Beyond clinical operations, I partnered with medical affairs and marketing to bridge science and strategy, support publication planning, and prepare the organization for inspection readiness and commercialization. What excites me most is building high-functioning teams, fostering strong site and vendor partnerships, and teaching others to think strategically about research. I am passionate about advancing eye care through collaboration, innovation, and patient-centered solutions — with the ultimate goal of improving lives through better vision. Core Areas: Clinical Development • Clinical Operations • Program Management • Ophthalmology • Cell Therapy • Drug & Device Trials • Regulatory Strategy • Cross-Functional Leadership • Medical Affairs • Strategic Planning • FDA Submissions • Team Building

Experience

1. Director of Clinical Development Operations

   Aurion Biotech

   Sep 2025 — Present · Omaha, NE, US

   As Director of Clinical Development Operations, I lead the planning, execution, and integration of Aurion’s clinical development programs, with a focus on advancing first-in-class therapies in corneal endothelial cell therapy. My role bridges science, strategy, and execution. Ensuring that timelines, resources, and cross-functional collaboration align with corporate objectives and ultimately bring transformative treatments to patients.Key responsibilities include-Driving operational strategy and execution across global Phase 3 trials-Partnering with cross-functional leaders (clinical, regulatory, medical affairs, and commercial) to align development milestones with corporate OKRs and long-range planning-Overseeing site relationships, trial governance, SOP build-out, and surgical training-Ensuring programs run efficiently within scope, budget, and compliance requirements-Contributing to Aurion’s publication strategy and scientific communications to strengthen our leadership in ophthalmology innovation-Serving as a connector across teams to anticipate challenges, identify solutions, and support seamless program execution.

Education

• Johns Hopkins University Advanced Academic Programs

  Graduate Courses, Research Administration

  2020 — 2021

• Northeastern University

  DMSc, Medical Clinical Sciences/Graduate Medical Studies

  2026 — 2028

• South Dakota State University

  Bachelor of Science (B.S.), Biology

• Liberty University

  Graduate Courses, Finance, General

  2023 — 2025

Skills

• Hospitality Industry
• Revenue Analysis
• Microsoft Word
• Teamwork
• Helping Team Members Find Their Unique Abilities
• Hotel Management
• Leadership
• Time Management
• Hospitality Management
• Marketing
• Make Things Happen
• Hospitality
• Public Speaking
• Resorts
• Hotels
• Clinical Trials
• Clinical Monitoring
• Customer Service
• Event Planning
• Certified Clinical Research Coordinator
• Sales
• Project Management
• Ophthalmology
• Microsoft Excel
• Powerpoint
• Clinical Research