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 within the Immunology & Inflammation Therapeutic Area 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 developmen t 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. 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.
At the project level, the Clinical Lead, ECET will be a member of the Translational Medicine subteam. Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into to 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; Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaises with partners on projects.
Ensure an adequate follow-up of studies and project timelines.
Present data at appropriate meetings (inside or outside Sanofi).
Present data at appropriate meetings (inside or outside Sanofi).
Spokesperson of TMU and Clinical Patient Sciences; Take an active part in the scientific challenges involved in early clinical development, which require a scientifically inquisitive, energetic and proactive person.
Requires excellent communication skills and the implementation of an appropriate process for communication.
Ensure high quality documents, requiring strong writing and communication skills.
Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety, information for Regulatory authorities.
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.
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. 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 documents, etc.).
Ensure proper documentation is provided to the Ethics Committees and Health Authorities.
Prepare and review the interim investigator reports.
Participate in the data review and validation meetings before database lock.
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.
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.
Experience in basic science, translational medicine and/or clinical reserach (mandatory)
~ Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
Demonstrated capability to challenge decision and status quo with a risk-management approach
Medical.
International/ intercultural working skills
Education :
laboratory research in industry or academia is a plus.
fluent in English
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. Ready to chase the miracles of science and improve people’s lives? Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. Ready to chase the miracles of science and improve people’s lives?