Our client is seeking a Clinical Scientist 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.
Position Title: Clinical Scientist
Location: We are prioritizing candidates based in Taiwan or U.S.-based candidates willing to relocate to Taiwan for at least one year. If we're unable to identify ideal candidates, we will then consider hiring for our Bay Area site.
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
