Clinical Scientist

Job Title: Clinical Scientist

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical & Sciences Operations Platform (CSO) and Development Units in Sanofi R&D.

The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director in the medical/scientific contribution for the clinical studies e.g: supporting operational activities pertaining to the abbreviated protocol/protocol/amended protocol development (such as Informed consent, committees charters development), support to validation and clinical case review of study data, review of study plans and draft study reports/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, help manage study committees.

Scope includes all R&D clinical trials for Tolebrutinib, from scientific assessment of a clinical project to final deliverable. The applicant must be able to use digital reporting tool, convinced and willing to promote their use. The applicant is a fast learner as the role can be assigned to any Therapeutic Area depending on needs.
Under the guidance of the CRD he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical review, as needed. He/she supports the CRD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

To better serve the activity, and depending on his/her experience, a Clinical Scientist can be dedicated to a specific task with minimal supervision (e.g. answering questions of local teams, managing validation strategy etc…), following business needs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Ensure scientific support for realization of tolebrutinib study(ies) he/she is allocated to by securing the operationalization of the medical validation/review plan (reports and trackers)

• Contribute to preparation and/or review of any documents related to the studies and requiring a scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form). Participates with the Study Team and monitoring team training on medical information

• Is assessing, providing cost elements related to the study support in collaboration with study team, including planning management

• Support CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project

• Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of rationalizing and documenting the data collection needs quantitatively and qualitatively

• Contribute to definition of the centralized monitoring strategy in consistency with the planned statistical analysis and is involved some of the study data validation and review processes, support the CRD for the Clinical Case review (safety events reported to Pharmacovigilance or safety events of special interest)

• Help for the preparation, organization, conduct and minutes of Study Committees (eg. IDMC), follow the contracts with business support

• Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudicati