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.
Responsibilities:
-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.
Qualifications:
-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
