Senior Medical Director, Clinical Research
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. This position may also require up to 20% travel
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, Clinical Research will report to the Head of Early Development and will be responsible for the advancement of multiple early clinical development programs. The incumbent 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.
The Senior Medical Director will:
• 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.
• 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.
• This position requires a minimum of an advanced degree in medicine (i.e. M.D or DO or equivalent) in relevant area with substantial medical/clinical training in infectious diseases.
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.
North America-United States-California-South San Francisco
Other Location: North America-United States-New Jersey-Raritan
Alios BioPharma, Inc. (6224)
Clinical Research MD