Senior Clinical Trials Scientist

CG Oncology

4h•Remote

About The Position

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.

Requirements

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

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.