Clinical Research Director, Immuno-Inflammation Development

<p><i>Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.</i>  </p><p></p><p><i>This job offer is accessible to all, regardless of gender.</i> </p><p></p><p><b>Job title</b>:<i> Clinical Research Director, Immuno-Inflammation Development</i></p><p></p><ul><li><i>Location:</i> <i>Gentilly, Campus Val de Bièvre </i></li></ul><p></p><h1><i>About the job</i></h1><p></p><p><span><span>The </span><b><span>Development Medical Director</span></b><span> (DMD) / <b>Clinical Research Director</b> (CRD) is a key clinical lead in the Development of R&amp;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.</span></span></p><p></p><p><b>About Sanofi:</b></p><p></p><p>We’re an R&amp;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.</p><p><span><span> </span></span></p><p><b><span><span>The role of the DMD/CRD is to:</span></span></b><br/> </p><ul><li><span>Collaborate with other medical and clinical scientific experts DMDs/CRDs 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</span></li><li><span>Provide clinical scientific expertise in the Study team to conduct the clinical studies from early phases to LCM programs</span></li><li><span>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.)</span></li><li><span>   Provide appropriate clinical scientific input &amp; 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 </span></li><li><span>   Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc.) and answer to questions from health </span><span>authorities </span></li><li><span>Be the scientific &amp; medical reference in the Study team, ensuring the medical relevance of the clinical data </span></li><li><span>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.)</span></li></ul><p><span><b><span> </span></b></span></p><p><span><b><span>Leading the clinical development plan strategies:</span></b></span></p><p></p><ul><li><span><span>Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)</span></span></li><li><span>Collaborate with other DMDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams</span></li><li><span>Raise study or project-level issues to the project head and propose related corrective action plans</span></li><li><span><span>Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects</span></span></li><li><span><span>Collaborates with external partners, regulators, scientific experts and internal stakeholders</span></span></li><li><span>Raise study or project-level issues to the project head and propose related corrective action plans</span><span> </span></li><li><span><span>Evaluates relevant medical literature and status from competitive products</span></span></li></ul><p><span><span> </span></span></p><p><span><b><span>Lead, Support and oversee the execution of clinical development and studies activities:</span></b></span></p><p></p><ul><li><span><span>Collab