Clinical Scientist

Sanofi • Cambridge, MA

2d

About The Position

About the Job Our Team: The Lunsekimig project team is part of Early Development in the Inflammation & Immunology Therapeutic Area at Sanofi. Our team is developing a novel pentavalent, bispecific Nanobody for the treatment of asthma and other “Type 2” inflammatory diseases. Lunsekimig is being evaluated across multiple respiratory indications as well as atopic dermatitis. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main responsibilities: The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies, on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes. Strategic clinical development plans: 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. Clinical trial execution: 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. Team development: 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 About You Education and experience: Advanced degree preferred (PharmD or PhD scientist or Biomedical Science master with previous experience in Clinical Research and/or Clinical Drug Development).

Requirements

• 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).

Nice To Haves

• Experience with interaction with regulatory Authorities for clinical trials is a plus.
• 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.

Responsibilities

• The primary purpose of the Clinical Scientist’s position is to assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies, on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.
• 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

Benefits

• 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.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees