Who we are?
As a global healthcare leader and a Global Top Employer, we are as much a partner to patients facing health challenges as we are a partner to you on your career journey. We are focused on empowering our people to be agents of change, because the work we do will change health outcomes and empower patients’ lives. This is where you will have access to a broad track for all-round development as well as the platform to work as one team across one of the broadest healthcare and well-being portfolios globally.
Why start your career path in Sanofi?
Here, you can:
· Copperate with strong, independent technology group and experience digital & innovative ways of working
· Be viewed as a trusted partner, shared goals and quality work
What you can contribute?
· This role is key to help the medical supervision of clinical studies by Clinical Study Directors and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) of Sanofi R&D.
· The primary purpose of the Clinical Scientist’s (CSc) position is to assist/support the Clinical Study Director (CSD) in the medical/scientific contribution for the clinical studies. e.g: contributing/reviewing of extended synopsis, protocols, amendments, amended protocols, support to medical review of study data (especially safety data with reconciliation), review of draft study reports or draft publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, helps manage study committees.
· Scope include all clinical trials for projects in development (excluding Phase I in healthy subjects, Phase I onco and POC managed by CEP) and clinical studies (e.g. registries) for marketed drugs or devices, from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD, …).
· Under the guidance of the CSD and/or OMD&CD management : he/she collaborates with the Coding specialist, Biostatisticians, CTOMs, R-TMs, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g.review of narratives) on high quality medical review, as needed. He/she supports the Head Clinical Scientists, Medical Coding & Review, and functionnally the CSD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
· Ensure scientific support for operational realization within the CSO for study(ies) or registries he/she is allocated to, under the functional supervision of the CSD and/or OMD&CD management, by securing the operationalization of the medical validation/review plan (reports and trackers).
· Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of decreasing the complexity.
· Is involved in some of the medical reviews of study data under the CSD supervision, support the CSD for the medical review of data with the manual reconciliation of the case by case review of safety events reported to GPE or safety events of special interest, listings.
· Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (extended synopsis, protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form…). Participates to the CTT and monitoring team training on medical information.
· Provide or prepare medical or scientific information/documentation/analysis when appropriate for protocol preparation or study conduct.
· Support CSD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project.
· Support to regulatory documents filing and archiving.
What you should have?
· MD, Ph.D., Pharm.D., or similar; bachelor degree considered for candidates with experience.
· Previous experience in Clinical Research and/or Clinical Drug Development (e.g., at least 10 years within pharma industry or CRO).
· Scientific expertise or interest and ability to learn in the domain of assigned study/project.
· Strong English skills (verbal and written if English is the second language)
If you want to be part of a team that puts patients first, plays to win in digital era with courage, integrity, respect and trust, to inspire your own career journey through a care & collaborate platform, and with special focus on below competency:
· High level of autonomy and motivation
· Quality focused and well organized
· Strong communication skills (verbal and written)
· Ability to handle multiple tasks and to prioritize
· Ability to synthesize the information, good presentation skills
· Ability to work autonomously and to efficiently & effectively provide status reports
· Ability to anticipate and timely escalate issues and to define appropriate action plans
· Team and results oriented
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.