Our client is seeking an Associate Director, Clinical Science to join our 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 (e.g., oncology, immunology, cell biology, or nursing): Ph.D./MD/PharmD with 8-12+ years of experience, or M.S. with 12-15+ years of experience.
• Minimum of 5 years of experience in clinical research, with track record for performing study design, set up, and clinical data review.

Responsibilities include, but are not limited to:

• Develop and oversee clinical trial protocols, ensuring alignment with regulatory guidelines and strategic objectives.
• Lead cross functional study set up activities for successful conduct of the study, in collaboration with ClinOp, data management, Regulatory, and vendors.
• 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.
• 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
• Proficient in statistical analysis, clinical data review and interpretation
• Experience in the follow areas are preferred oncology, or rheumatology/autoimmune disease, and cell therapy
• Experience in successful regulatory submissions is plus