Job Description:

Industry: BiotechnologyPosition: Clinical Scientist IIILocation: Cambridge, MA (Hybrid: 3 days per week remote)Duration: 12 months contract (+Possibility of extension)Details: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 company's R&D.The primary purpose of the Clinical Scientist's position is to assistsupport the Clinical Research Director in the medicalscientific contribution for the clinical studies e.g: supporting operational activities pertaining to the abbreviated protocolprotocolamended protocol development (such as contribution to writing of protocol andor amendments, informed consent, committees charters development and other study ancillary documents), support in the validation and clinical case review of study data, review of study plans and draft study reportspublications for accuracy, search of medicalscientific 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 Riliprubart in CIDP (chronic inflammatory demyelinating polyneuropathy), 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 must be a fast learner as the work needs can change and evolve over time based on project progress. The applicant must be familiar with all medical and operational aspects related to the conduct of late-stage clinical trials.Under the guidance of the CRD heshe 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. Heshe 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 hisher 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.Main Responsibilities:Ensure scientific support for the conduct of Riliprubart study(ies) heshe is allocated to by securing the operationalization of the medical validationreview plan (reports and trackers)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)Contribute to preparation andor review of any documents related to the studies and requiring a scientific background (submission portfolio, abbreviated protocolprotocolamended protocol, patient written information, presentationscommunication to internal or external partners, study plans, study reports, trial disclosure form). Participates with the Study Team and monitoring team training on medical informationSupport CRD in the preparation of medical answers to questions from Health Authorities, IRBEthics Committees, investigators, experts involved in the studyproject as neededIs involved in the quality and update of study documents, CRF adequacy with protocolsprotocol amendments and will help in the objective of rationalizing and documenting the data collection needs quantitatively and qualitativelyHelp for the preparation, organization, conduct and minutes of Study Committees (eg. IDMC), follow the contracts with business support as neededSupport CRD in organizingleading Steering committees, Data Monitoring Committees, Adjudication Committee meetings as neededSupport to regulatory documents filing and archiving.Is assessing, providing cost elements related to the study support in collaboration with study team, including planning management as neededRequired Knowledge and Skills:Understand data collection, data flow, data validation, including medical validation and review processes up to data analysisAble to develop good quality management practices, including guidelines, as regard to medical data review activities, using a data-driven and risk management approachDigital and data orientedScientific expertise or interest and ability to learn in the domain of assigned studyprojectAbility to take responsibilities on medical activities or endorse CRD decisions on hisher behalfQuality focused, detail-oriented and well organizedAbility to handle multiple tasks and to prioritizeStrong communication skills (verbal and written)Ability to synthesize the information, good presentation skillsAbility to work autonomously and to efficiently provide status reportsAbility to anticipate and timely escalate issues and to define appropriate action plansTeam and results orientedStrong English skills (verbal and written if English is the second language)Required EducationExperience:MD, Ph.D., Pharm.D., or similarPrevious experience in Clinical Research andor Drug Development (e.g., at least 5-10 years within pharma industry or CRO or other clinical trial sites).Previous senior clinical experienceMinimum of 5 years of clinic experience, review data, operation, and clinic dataExperience with Quality, deviations, Protocols and consentsMust have experience in late-stage clinical trials, medical monitoring, and data reviewsPrevious experience with medical validations reviews adverse events Nice To Have Preferred:Previous experience in neurology, neuroscienceMedical writing experience (drafting consents or protocols) • Medical safety experience is a plus