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.
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
Well-Being Benefits
In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.
Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2026 we will observe 14 holidays
- RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
CG Oncology is an Equal Opportunity Employer:
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
Top Skills
CG Oncology Irvine, California, USA Office
400 Spectrum Center Drive, Suite 2040, Irvine, CA, United States, 92618
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