Johnson & Johnson's Family of Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including: oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
The Senior Medical Director, Infectious Diseases will report to the Head of Early Development and will be responsible for the advancement of multiple early clinical development programs. The incumbent, in close collaboration with the Early Clinical Development Team Leader, will 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.
- Act as clinical representative on one or more Early Clinical Development Teams
- Contribute to the design of clinical development programs and ensure that clinical trials meet ethical and regulatory standards.
- Work closely other disciplines within Janssen Pharmaceuticals to advance programs.
- Lead the Clinical sub team(s) responsible for implementing clinical trial programs.
- 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.
- Work closely with Discovery and Translational scientists to develop biomarker strategies
- 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.
- 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.
- An advanced degree in medicine (i.e. M.D or DO or equivalent) with substantial medical/clinical/basic science or translational science training and experience in infectious diseases is required.
- A minimum 5 years of experience designing, leading and managing clinical trials in infectious diseases within the pharmaceutical industry is required.
- Experience of managing early stage programs within the industry or as a clinical investigator is required.
- Experience in the areas of hepatology (particularly chronic hepatitis B) and/or acute respiratory viral infections (particularly influenza or RSV) and/or HIV is preferred.
United States-California-South San Francisco-
Janssen BioPharma, Inc. (6224)
Clinical Research MD