Senior Clinical Trials Scientist

About the role

The Senior Clinical Trials Scientist (Sr CTS) provides scientific leadership and mentorship across Clinical Development and Operations teams but does not include formal line management or direct reports. 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

• Provide scientific leadership for the 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 through matrixed and collaborative relationships.
• 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 scientific leadership and mentoring capabilities in cross‑functional or matrixed environments.
• 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 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.