Our client is seeking an Senior Clinical Scientist to join the clinical development team. The ideal candidate will play a critical role in the design, implementation, and analysis of clinical trials focused on our advanced cell therapy programs. You will collaborate with cross-functional teams to ensure the scientific rigor and operational success of our clinical studies.
Education /Background
Advanced degree in a relevant scientific discipline
Minimum of 5 years of experience in clinical sciences, with track record for performing study design, set up, and clinical data review.
Responsibilities include, but are not limited to:
Assist or lead drafting responses to regulatory agencies, IRB/EC, and study sites related to the study protocol, and ensure timely response to these requests.
Implementing protocols : data collection design (EDC, ePRO, eCOA), blinded or OL data review on safety and efficacy, to monitor study progress.
Perform periodic ongoing clinical data review from various EDC systems, contributing to the interpretation of results and providing actionable insights for study progression and decision-making.
Prepare and review clinical study reports, regulatory submissions, and manuscripts for scientific publication, ensuring accuracy and compliance. Manage drafting and review of study narratives for important adverse events as needed.
Interact with regulatory agencies to support clinical trial applications and maintain compliance with regulatory standards.
Position Requirements & Experience
Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
Experience in the follow areas are preferred rheumatology/autoimmune disease, and/or CAR-T