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