Clinical Lead Early Clinical and Experimental Therapeutics

Job title : Clinical Lead Location: Cambridge, MA About the Job Your skills could be critical in helping our teams accelerate progress. Join our state-of-the-art ECET department as a Clinical Lead, ECET and you’ll drive the translation between preclinical development through early clinical development and beyond, while enjoying lots of opportunities to broaden your experience and hone your skills. This position located within the Translational Medicine Unit (TMU)/Clinical and Patient Sciences (CPS) / Early Clinical and Experimental Therapeutics (ECET) is responsible for ECET contributions across all therapeutic areas at Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities. The individual in this position is an integral part of the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical development including early and rapid Proof-of-Mechanism/Proof-of-Concept, as well as natural history studies and experimental model validation to contribute building the Human Target Validation (HTV) and to evaluate the pharmacology of novel therapeutic approaches. Additionally, to identify potential signals of efficacy or safety notably for new indications and gain better understanding on the mode of action, signal seeking clinical and mechanistic trials are in the scope of expertise for this role.  Collaborative interactions with research scientists, toxicologists, pharmacokineticists, modelling & simulation experts, biomarker experts, and late phase therapeutic area clinicians are critical to success in the role.  The ability to integrate the outputs of multiple disciplines into a coherent translational medicine and human target validation plan is essential. 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: At the project level, the Clinical Lead, ECET will be a member of the Translational Medicine subteam.  In these roles, duties include: Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating it into the overall development strategy in collaboration with the responsible Therapeutic Area in research and development. Design safe, rapid and informative First-In-Human studies including First In Patients, natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions, and other pharmacokinetic studies. Supervise the execution and ensure close medical monitoring. Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaise with partners on projects. Participate in the dose selection for First-In-Human studies, drive Go/No Go decisions when needed. Ensure an adequate follow-up of studies and project timelines.  Present data at appropriate meetings (inside or outside Sanofi). Major Challenges and opportunities: Spokesperson of TMU and Clinical Patient Sciences; requires a committed and enthusiastic person to emphasize the strengths of the position and a positive, collaborative mindset. Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person. Ensure Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication. Ensure high-quality documents, requiring strong writing and communication skills. Manage aggressive timelines effectively through cross-functional planning. Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety. Provide information for Regulatory authorities. Key Internal/External Relationships: Internal contacts: Other TMU departments (mainly PreClinical Safety, Laboratory Sciences, Quantitative Pharmacology, Operations and Evidence Generation & Decision Science), Early Development Clinical Operations (EDCO, including Clinical Trial Managers and Data Managers), Regulatory Affairs, Patients Safety & Pharmacovigilance, Therapeutic Area Research & Development Groups. External contacts: Investigators, Clinical Site Services Providers, early phase Clinical Research Organizations, clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives. At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities include: Study preparation: Design and conduct early clinical development studies including phase 2a within planned timelines (supported by an operational team). Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory