Senior Clinical Research Director

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About the role

Job title : Senior Clinical Research Director • Location: Cambridge, MA Clinical Research Director (Sr CRD) is the primary clinical lead for programs. The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks. The role of the Senior CRD is to: • Act as a mentor for other CRDs and Clinical Scientists on within the project/Therapeutic Area (TA). • Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams. Take on as necessary the CRD role: • Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report). • Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment). • Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities. • Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators. • Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data. • Interact with other CRDs in the project, Global Project Head, Pharmacovigilance, Regulatory and other key functional reps. 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. 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: Lead the clinical development plan strategies: • Prepare documents and presentations for internal governance meetings. • Responsible for the clinical development plans and clinical sections of integrated development plans (IDP). • Collaborate with other CRDs within the project, providing leadership and building consensus. • Coordinate action plans with stakeholders to resolve project-related study issues, anticipating potential issues (sharing lessons learned) across the project or study teams • Raise study or project-level issues to the project head. • Contribute to the definition of the product value proposition (TVP), 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. • Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators. • Evaluates relevant medical literature and status from competitive products. Lead, support and ove

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