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Senior Clinical Trials Scientist jobs in United States
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CG Oncology · 1 month ago

Senior Clinical Trials Scientist

CG Oncology, Inc. is focused on Attacking Bladder Cancer for a Better Tomorrow, seeking to make significant advancements in immunotherapies. The Senior Clinical Trials Scientist will provide scientific leadership for the planning, design, and implementation of global Phase II-III clinical trials, ensuring adherence to regulatory and ethical standards.
BiotechnologyHealthcareMedical DeviceHealth CareHealth DiagnosticsOncology

Responsibilities

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

Qualification

Clinical trial designClinical trial executionRegulatory document developmentICH-GCP guidelinesFDA regulationsEMA regulationsClinical trial methodologyClinical writingData interpretationMentoring in clinical research

Required

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

Benefits

HIGHLY COMPETITIVE SALARIES
ANNUAL PERFORMANCE/MERIT REVIEWS
ANNUAL PERFORMANCE BONUSES
EQUITY
SPECIAL RECOGNITION
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

Company

CG Oncology

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CG Oncology is a clinical-stage biopharmaceutical company focused on the development of oncolytic immunotherapies to combat cancer.

Funding

Current Stage
Public Company
Total Funding
$555.57M
Key Investors
Foresite Capital,TCG CrossoverDecheng Capital,Longitude Capital,ORI CapitalKissei Pharmaceutical
2024-12-12Post Ipo Equity· $238M
2024-01-25IPO
2023-08-02Series F· $105M

Leadership Team

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Arthur Kuan
Chairman and CEO
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Jim DeTore
Chief Financial Officer
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Company data provided by crunchbase