Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Medical Director to be located in South San Francisco, CA and may require up to 20% travel.
Johnson & Johnson research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals.
The Senior Medical Director will:
- Report to the Head of Early Development and will be responsible for the advancement of multiple early clinical development programs.
- Have responsibility for developing strategy, designing and executing clinical development programs, and proving medical leadership primarily through proof-of-concept and potentially through full development.
- Design clinical development programs and ensure clinical trials meet ethical and regulatory standards. Work closely with the early Clinical Development Team Leader and may participate in one or more Clinical Development Teams while interacting with other disciplines within Janssen Pharmaceuticals.
- Provide medical monitoring support and oversight for early stage clinical trials.
- Act as primary medical reviewer for designated studies and ensure review and interpretation of efficacy and safety data from clinical trials.
- Oversee and participate in report and scientific writing activities for designated protocols including clinical study reports, scientific abstracts, presentations and publications.
- Provide input and/or review for other key clinical and regulatory documents such as investigator Brochures, and Clinical Trial Applications.
- Present and discuss clinical data at team, governance, KOL and regulatory meetings.
- Establish and maintain working relationships with clinical trial investigators, key opinion leaders, academicians, and senior management and department heads at Alios and Janssen.
- May also contribute to review and diligence activities related to potential compound or business acquisitions or partnerships.
- Ensure adherence to established timelines and budgets while ensuring regulatory compliance.
- Ensure clinical and scientific awareness in area of expertise.
- A minimum of an advanced degree in medicine (i.e. M.D or DO or equivalent) in relevant area with experience in clinical/drug development in infectious diseases is required.
- A minimum 5 years of experience designing, leading and managing significant clinical trials including infectious diseases in the pharmaceutical industry including early stage programs is required.
- Antiviral experience is preferred.
- This position is located in South San Francisco and may require 10-20% travel.
United States-California-South San FranciscoOrganization
Alios BioPharma, Inc. (6224)Job Function
Clinical Research MDRequisition ID