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.

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.

Under the guidance of his/her manager in the I&I Therapeutic Area, 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 scientific documents, as needed. He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

1. Strategic clinical development plans:

• Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background (i.e.: 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 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

2. 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
• 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

3. Team development:

• Maintain scientific, technical, and clinical expertise in immunology, dermatology, pulmonology, or other disease areas within the Immunology and Inflammation therapeutic area

About you

Skills that you have (mandatory):

• Advanced degree preferred (PharmD or PhD scientist or Biomedical Science master with previous experience in Clinical Research and/or Clinical Drug Development)
• 2+ years of industry experience (clinical development)
• Experience of working internationally with Strong English skills (verbal and written if English is not the native language
• Experience with supporting preparation and execution of clinical trials
• Experience with interaction with regulatory Authorities for clinical trials is a plus
• 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

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