Location: 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 assist/support the Clinical Research Director in the medical/scientific contribution for the clinical studies e.g: supporting operational activities pertaining to the abbreviated protocol/protocol/amended protocol development (such as contribution to writing of protocol and/or 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 reports/publications for accuracy, search of medical/scientific 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 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 review, as needed. He/she 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 his/her 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) he/she is allocated to by securing the operationalization of the medical validation/review 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 and/or review of any documents related to the studies and requiring a scientific background (submission portfolio, abbreviated protocol/protocol/amended protocol, patient written information, presentations/communication to internal or external partners, study plans, study reports, trial disclosure form). Participates with the Study Team and monitoring team training on medical information
Support CRD in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project as needed
Is involved in the quality and update of study documents, CRF adequacy with protocols/protocol amendments and will help in the objective of rationalizing and documenting the data collection needs quantitatively and qualitatively
Help for the preparation, organization, conduct and minutes of Study Committees (eg. IDMC), follow the contracts with business support as needed
Support CRD in organizing/leading Steering committees, Data Monitoring Committees, Adjudication Committee meetings as needed
Support 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 needed
Required Knowledge and Skills:
Understand data collection, data flow, data validation, including medical validation and review processes up to data analysis
Able to develop good quality management practices, including guidelines, as regard to medical data review activities, using a data-driven and risk management approach
Digital and data oriented
Scientific expertise or interest and ability to learn in the domain of assigned study/project
Ability to take responsibilities on medical activities or endorse CRD decisions on his/her behalf
Quality focused, detail-oriented and well organized
Ability to handle multiple tasks and to prioritize
Strong communication skills (verbal and written)
Ability to synthesize the information, good presentation skills
Ability to work autonomously and to efficiently provide status reports
Ability to anticipate and timely escalate issues and to define appropriate action plans
Team and results oriented
Strong English skills (verbal and written if English is the second language)
Required Education/Experience:
MD, Ph.D., Pharm.D., or similar
Previous experience in Clinical Research and/or Drug Development (e.g., at least 5-10 years within pharma industry or CRO or other clinical trial sites).
Previous senior clinical experience
Minimum of 5 years of clinic experience, review data, operation, and clinic data
Experience with Quality, deviations, Protocols and consents
Must have experience in late-stage clinical trials, medical monitoring, and data reviews
Previous experience with medical validations/ reviews/ adverse events Nice To Have/ Preferred:
Previous experience in neurology, neuroscience
Medical writing experience (drafting consents or protocols) • Medical safety experience is a plus