Sanofi · 1 day ago
Clinical Scientist
Cambridge, MA
Full-time
Hybrid
Senior Level
5+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Clinical Scientist will assist the Clinical Research Director in the medical/scientific contributions for clinical studies, managing operational activities from clinical trial set-up to clinical study report in compliance with regulatory processes.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (ie abbreviated protocol/protocol/amended protocol, presentations/communication to internal or external partners, study reports, committee charters, protocol registration form, redacted protocol, lay summary)
Supports Clinical Research Director in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring, to implement/develop related sections of the study risk management plan
Support the Clinical Lead and CRD to prepare presentations to obtain endorsement of the clinical strategic plan with the appropriate governance committees
Support program strategy including clinical development plan and regulatory needs
Work in partnership with CRD or Clinical lead as functional liaison (data management, biostatistics, medical writing, pharmacovigilance, regulatory, clinical operations, translational medicine) as well as interact with and support Project team members, project management, medical affairs
Support the design and execution of clinical studies defined within development plan
Support the preparation of key clinical documents to be prepared for clinical trials (protocols, informed consent, charters, benefit risk assessments)
Is involved in the update of study documents, eCRF adequacy with protocols/protocol amendments and helps in rationalizing and documenting the data collection needs quantitatively and qualitatively and decreasing the complexity
Develops study specific training material and participates in the Investigators, Study Team, and monitoring team training on medical information
Contributes to definition of the centralized monitoring strategy in consistency with the planned statistical analyses and is involved in study data validation and review processes, supports the CRD for the Clinical Case review (safety events reported to GPV or adverse events of special interest), notably to anticipate and prevent last minute queries or backlog and smoothen the process
Understand data collection, data flow, and data validation processes, including medical validation and review procedures through to data analysis. Develop high-quality management practices and guidelines for medical data review activities using a data-driven and risk-based approach
Supports CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings
Supports regulatory documents filing and archiving
As appropriate and not limited to, contribution to and review of study plans, study reports, briefing package, Investigator brochure (IB), Development Safety Update Report (DSUR), clinical parts of submission dossier, publications for accuracy with clinical study report as well as ensuring completeness of study reports appendices under the responsibility of the CRD
Support CRD and Study Team with study start-up, site opening, enrolment monitoring and supporting
Support CRDs, Clinical Lead and Global Project Head with cross-programs strategy and activities
Maintain scientific, technical, and clinical expertise in immunology, dermatology, pulmonology, or other disease areas within the Immunology and Inflammation therapeutic area
Qualification
Required
Advanced degree preferred (PharmD or PhD scientist or Biomedical Science master with previous experience in Clinical Research and/or Clinical Drug Development)
5+ years of industry experience (clinical development)
Experience with supporting preparation and execution of clinical trials
Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance
Experience in successful collaboration with cross-functional global teams of interdisciplinary professionals
Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., investigators, vendors and CROs)
Open, transparent, collaborative working style
Good leadership, interpersonal, communication, and presentation skills
Good problem-solving, conflict-resolution and decision-making skills
Driven individual and performance oriented with ability to work along agreed timelines
Proven ability to manage projects/team of significant scope and complexity, while meeting all deliverables and timelines
Preferred
Experience with interaction with regulatory Authorities for clinical trials is a plus
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-17
Company data provided by crunchbase