Jobs · Analyst · New Jersey

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)

Similar jobs