Senior Clinical Trials Scientist

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

• The Senior Clinical Trials Scientist (Sr CTS) plays a key leadership role within the Clinical Development and Operations teams at CG Oncology. This individual will lead the scientific and strategic execution of global Phase II-III clinical trials, acting as a primary scientific expert in cross-functional teams and external collaborations. The Sr. CTS contributes to the development of clinical strategy and ensures the integrity of clinical trial design, implementation, data analysis, and reporting. The ideal candidate is a seasoned professional with demonstrated ability to lead clinical programs in complex therapeutic areas, particularly oncology.

Location: Remote

Essential Functions

• Lead the scientific planning, design, and implementation of complex Phase II-III clinical trials, ensuring adherence to regulatory, ethical, and scientific standards.
• Author and/or provide critical review of study protocols, amendments, informed consent documents, clinical study reports (CSRs), and other clinical documentation.
• Serve as a scientific liaison across cross-functional teams including Clinical Operations, Regulatory Affairs, Pharmacovigilance, Biometrics, Quality, and Clinical Supply Chain to drive timely and efficient execution of studies.
• Partner with external stakeholders (CROs, vendors, investigators) to ensure study conduct meets internal quality standards and regulatory compliance.
• Oversee and provide scientific input into data review, including listings, tables, and figures, and contribute to interim and final data analysis and interpretation.
• Participate in the development of regulatory documents, including briefing books, IND/NDA/BLA submissions, and responses to health authority inquiries.
• Support and/or lead the preparation and conduct of investigator meetings, advisory boards, and scientific presentations.
• Mentor and provide technical guidance to Clinical Trials Scientists and other junior team members.
• Contribute to clinical strategy discussions and development plans in collaboration with medical and strategic leadership.

Qualifications

• Master’s degree in a scientific or health-related field (e.g., biology, pharmacology, public health).
• Seven plus (7+) years of experience in clinical research/drug development, with demonstrated experience in clinical trial design and execution.
• Experience with regulatory document development and regulatory agency interactions.
• Strong knowledge of ICH-GCP guidelines, FDA/EMA regulations, and clinical trial methodology.
• Exceptional written and verbal communication skills, including clinical writing and data interpretation.
• Proven ability to manage multiple projects with high attention to detail in a fast-paced, high-growth environment.
• Demonstrated leadership and mentoring capabilities.
• Availability for ~10% domestic and international travel, including overnight stays.
• Flexible work hours to accommodate global team collaboration.

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