Development Scientific Director, I&I

Job Title : Development Scientific Director

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Location : Morristown, NJ

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.

The Development Scientific Director (DSD) is a key scientific lead in the Development of R&D programs . The role requires a well-organized, strategically, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.

The role of the DSD is to :

• Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare / assist with regulatory bodies interaction
• Provide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programs
• Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc.)
• Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors / Clinical Project Leaders from Clinical Study Units, and investigators
• Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc.) and answer to questions from health authorities
• Be the scientific & medical reference in the Study team, ensuring the medical relevance of the clinical data
• Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc.)

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.

Main Responsibilities :

Leading the clinical development plan strategies :

Lead, Support and oversee the execution of clinical development and studies activities

Responsibilities related to regulatory and safety documents and meetings :

Scientific Data evaluation and authorship :

About You

Experience

Minimum Level of any Required Qualifications :

Why Choose Us

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. xklufbp Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. ( )