Amber Rosales

About Amber Rosales

I lead clinical operations programs that bring life-changing therapies to patients with significant unmet medical needs. With over 10 years of progressive experience in pharmaceutical clinical research, I’ve managed cross-functional programs from concept through completion—including contributing to FDA approval of a company’s first medication and leading a first-in-human (FIH) SAD trial resulting in a positive press release. and increase in stock price. I thrive on the complexity of global trials, managing timelines, budgets, and stakeholder expectations while keeping operational excellence and patient impact at the center of every decision. My experience spans Phases I–IV, post-marketing, and rare disease programs, with multi-million budget oversight and leadership across internal teams and CRO/vendor partnerships. Therapeutic expertise includes lupus nephritis, autoimmune disease, and rare diseases, with a proven ability to rapidly master new indications. I’ve also led key systems implementations, including Veeva Vault CTMS/TMF integration initiatives. For me, operational excellence isn’t just about hitting milestones—it’s about the patients waiting for breakthrough therapies. Every study I lead represents someone’s hope for a better quality of life. Currently seeking opportunities to lead clinical operations programs driving the next generation of breakthrough therapies. Clinical Trial Experience: Phases I – IV, post-marketing studies, global trials, first-in-human (FIH), single ascending dose (SAD), drug-drug interaction (DDI), pediatric populations, rare disease, autoimmune disease, specialized expertise in Lupus Nephritis

Experience

1. Senior Manager, Clinical Operations

   Aurinia Pharmaceuticals Inc.

   Mar 2025 — Present · Tempe, AZ, US

Education

• Danish Institute for Study Abroad

  Human Health and Disease

• University of Arizona

  Bachelor of Science - BS

• Universidad de Alcalá

  Intermediate/ Advanced Spanish