Summary: A Bay Area-based, start-up biotechnology company is currently seeking a motivated Medical Director/Senior Medical Director to manage their clinical trials. As Medical Director/Senior Medical Director, you will be responsible for the oversight and execution of clinical trials for their early-stage cell therapy programs. Are you eager to push the envelope of science and improve the quality of treatment for cancer patients? If yes, please reach out to learn more.
-Help develop and implement strategic plans, devise contingency plans, and provide technical and strategic advice.
-Work cross-functionally to design and execute clinical studies.
-Provide writing support for trial-related documents including protocols, investigator brochures, charters, clinical study reports and review of clinical trial documents.
-Lead investigator meetings and site initiation visits with clinical trial investigators.
-Must be an MD
-Experience in the biotech industry is a must, oncology practice experience is a plus
-Cell therapy clinical trials experience, early phase experience is a plus
-Experience participating in FDA documentation preparation, and a strong understanding of IND and NDA submissions
-Experience in medical monitoring and protocol design