Senior Enterprise Systems Administrator

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

CG Oncology is advancing innovative oncology therapies through global Phase I–III clinical trials. As we scale, the quality, integrity, and usability of our clinical and quality systems are mission-critical.

This role is not traditional “systems administration.” It is a hands-on systems ownership and leadership role with real authority over how clinical, quality, and regulatory systems enable execution, compliance, and growth.

If you enjoy owning systems end-to-end, partnering with Clinical Ops, QA, Regulatory, and CROs, and building scalable, audit-ready infrastructure in a growing biotech, this is a meaningful next step.

Location: Remote

Essential Functions

As Senior Enterprise Systems Administrator, you will:

• Own and lead CG Oncology’s clinical, quality, and regulatory enterprise systems (eTMF, CTMS, EDC, IRT, QMS, Veeva QualityDocs & Training, RIM Vault)
• Ensure systems are inspection-ready, compliant, and adopted across global Phase I–III trials
• Act as the business owner for systems strategy, validation oversight, continuous improvement, and user enablement
• Partner with CROs and vendors to ensure data quality, timelines, and budget discipline
• Play a visible role in regulatory inspections, audits, and submissions
• Help shape how systems scale as CG Oncology grows its pipeline

Qualifications

• Have 7+ years of progressive experience supporting enterprise clinical and quality systems in biotech, pharma, or a CRO
• Have supported full-cycle drug development (Phase I–III or I–IV), including audits or inspections
• Understand GCP, ICH, FDA expectations, and clinical data stewardship deeply
• Are comfortable owning systems, influencing cross-functional stakeholders, and working with external partners
• Thrive in a small, fast-moving biotech environment where priorities evolve and ownership matters
• Prefer roles where impact, accountability, and growth matter more than job titles alone

Why CG Oncology

• High-impact role with real ownership and visibility
• Direct influence on trial quality, inspection readiness, and scalability
• Collaborative, science-driven culture
• Opportunity to grow as a senior systems and quality leader as the pipeline advances

Oncology experience, small-biotech experience, and prior people leadership are strong pluses — but demonstrated performance and ownership matter most.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.