Ly Phan-Schupp
VP, Clinical Operations | End to end Drug Development | Global Trial Execution | IND–BLA Strategy | Program Leadership
- Role
- Vice President, Clinical Operations at Omeros Corporation
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Ly Phan-Schupp
Accomplished executive in Biotechnology and Pharmaceutical development with extensive experience leading Clinical Operations, Program Management, and Regulatory Strategy across early- and late-stage clinical programs. Currently serving as Vice President of Clinical Operations, I bring deep expertise in global clinical trial execution from first-in-human (FIH) through pivotal Phase and regulatory submissions (IND, BLA, MAA).Proven track record of building and scaling high-performing clinical teams, implementing operational best practices, and driving development timelines across multiple therapeutic areas. Skilled in strategic planning, portfolio oversight, CRO/vendor management, and aligning cross-functional teams across Regulatory, Preclinical, Biometrics, CMC, and Commercial functions.Trusted as a collaborative leader and operational strategist who delivers results in dynamic, fast-paced biotech environments. Passionate about advancing drug development through operational excellence, efficient execution, and a strong focus on quality and compliance.Core Competencies:• Vice President, Clinical Operations• Global Clinical Trial Execution (FIH – Phase Drug Development & Regulatory Submissions (IND, BLA, MAA)• Clinical Program & Portfolio Management• CRO & Vendor Oversight• Strategic Planning & Forecasting• GCP Compliance & Inspection Readiness• Budget Management & Contracting• Team Leadership & Functional Buildout• Cross-Functional Collaboration (Regulatory, Biometrics, CMC, Data Management, Medical Affairs)• Operational Excellence & Risk Management• Specializing in Rare Disease and Immunology
Experience
Vice President, Clinical Operations
Dec 2022 — Present · US
Led clinical operations across multiple programs, ensuring alignment with corporate objectives and strategic goals. • Established and optimized clinical trial processes, enhancing efficiency and compliance across all projects. • Managed relationships with CROs and external stakeholders, facilitating seamless execution of clinical trials. • Spearheaded risk management strategies, successfully mitigating potential challenges in clinical development.
Education
Seattle University
Bachelor of Science (B.S.), General Science
1994 — 1997
University of Arizona
Master of Business Administration - MBA
2020 — 2022
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