Clinical Research Director - Immunology and Inflammation
Sanofi · Morristown, NJ · 1 mo ago
On-siteAnalystFull-time
About the job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
Main Responsibilities
- Contributes to the development of the clinical strategy and plan
- Led the development of the Abbreviated Protocol and Protocol development
- Represents the clinical function on Clinical Study Teams and other teams as appropriate
- Participates in the review process for protocols, study reports, labeling, and interacts with regulatory agencies and ethics committees
- Ensures clinical data meets all necessary regulatory standards
- Serves as medical monitor for the studies assigned
- Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
- Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
- Participates in Advisory Committee preparation
- Ensures timely submission and dissemination of clinical data
- Supports the planning of advisory board meetings
- Establishes and maintains appropriate collaborations with knowledge experts
About You
- Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
- Minimum 2 years experience in pharmaceutical drug development and/or clinical research
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
- Strong scientific and academic background with deep understanding of the disease
- Clinical research or pharmaceutical experience in transplant/immunology field
- Knowledge of drug development and in immunology
- Good networking ability in cross-cultural environment
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Fluent in English (verbal and written communication)
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Qualifications
- Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
- Minimum 2 years experience in pharmaceutical drug development and/or clinical research
- Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus
- Strong scientific and academic background with deep understanding of the disease
- Clinical research or pharmaceutical experience in transplant/immunology field
- Knowledge of drug development and in immunology
- Good networking ability in cross-cultural environment
- Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
- Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
- Fluent in English (verbal and written communication)