Clinical Scientist

Summary: Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Clinical Scientist role is essential for supporting the medical supervision of clinical studies and ensuring scientific management of clinical studies related to Inflammation and Immunology development. Responsibilities: - Ensure scientific support for operational realization for assigned study/studies or registries by securing the operationalization of the medical validation/review plan (reports and trackers) - Contribute to preparation and/or review of documents requiring scientific background (abbreviated protocol/protocol/amended protocol, patient written information, presentations, study plans, study reports, trial disclosure forms) - Participate in Study Team and monitoring team training on medical information - Support CRD in preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts - Ensure quality and update of study documents, CRF adequacy with protocols/protocol amendments - Help rationalize and document data collection needs quantitatively and qualitatively - Contribute to definition of centralized monitoring strategy in consistency with planned statistical analysis - Support study data validation and review processes - Assist CRD for Clinical Case review (safety events reported to GPE or safety events of special interest) - Review and assess adverse events and protocol deviations - Assist in preparation of safety reports and regulatory submissions - Communicate effectively with CRD and study team on potential safety signals or study risks - Help with preparation, organization, conduct and minutes of Study Committees - Follow contracts with business support - Provide or prepare medical/scientific information/documentation/analysis for protocol preparation or study conduct - Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings - Support regulatory documents filing and archiving - Work closely with the Clinical Research Director (CRD) to implement study strategies and protocols - Under guidance of CRD, collaborate with Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers (GSMs and RSMs), Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) as needed - Support CRD to ensure appropriate documentation and consistency of data and investigations of safety cases with Clinical Trial Team (Monitoring Teams) or Pharmacovigilance - Collaborate with study team members to ensure alignment on study objectives and timelines - Participate in regular study team meetings to provide clinical input and updates - Partner with study team members to ensure data quality and integrity - Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis - Develop good quality management practices, including guidelines, regarding medical data review activities using data-driven and risk management approach - Ensure compliance with GCP, regulatory requirements, and company SOPs - Assess and provide cost elements related to study support in collaboration with study team, including GPPM - Promote, track, and accompany usage of electronic reporting solutions in context of medical review/validation Required Qualifications: - Advanced degree (PharmD, PhD, or Master's degree) in life sciences, pharmacy, or related field - 1-2 years of clinical development experience in pharmaceutical/biotech industry preferred - Strong knowledge of GCP, ICH guidelines, and regulatory requirements (FDA, EMA) - Understanding of clinical trial processes and adverse event reporting Preferred Qualifications: - Experience in Immunology/Inflammation therapeutic area - Clinical trial experience across multiple phases (Phase I-III) - Experience with clinical data management systems and eCRF platforms - Familiarity with medical terminology and disease pathophysiology Required Skills: Clinical development experience, GCP, clinical trials Important Skills: Experience in Immunology, Clinical data management systems, scientific writing Nice-to-Have Skills: Teaching skills, English skills, Problem-solving capabilities Benefits: High-quality healthcare, Prevention and wellness programs, At least 14 weeks’ gender-neutral parental leave