Development Scientifc Director, I&I

* The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (eg: protocol, Key Results, Clinical Study Report).
* Support other clinical development activities (e.g. pressure test and cluster feasibility, scientific review and validation of clinical data, study risk assessment).
* Contribute to the clinical part of Common Technical Document for FDA & EMA submission, answers to questions from health authorities for submission dossier) for their selected project.
* The Development Scientist will provide appropriate scientific input & support for all activities related to clinical studies such as protocol training, feasibility, scientific review of data, clinical scientific information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators.
* The Development Scientist will be the scientific reference in the Clinical Study team, ensuring the scientific relevance of the clinical data.
* He/she will have to interact with Global Project Head, The PV Rep, Regulatory and other key functional reps
* Provide expertise and act as a reference for all clinical scientific operational activities related to the projects/studies he/she is assigned to
* Write/contribute/review/QC/validate study related documents: clinical protocols, written subject information, trial disclosure form, Case report form, study plans (eg: study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators Meetings). Contribute to publications and communications of results.
* · Collaborate and communicate appropriately with all stakeholders for optimal study execution, including but not limited to:
* · Provide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost.
* · Responsible to support the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study related documents (eg: medical review plan, guidelines, etc…).
* May organize/contribute to Investigators’ Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (eg charter, presentations).
* Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.
* Secure Development Scientist trial master file documents readiness and availability, and mandatory trainings linked to the clinical function.
* Review/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc).
* Interact with assigned Medical Writers to develop, review and finalize study protocols and reports.
* Maintain clinical scientific expertise in the therapeutic domain, including very good understanding of underlying disease biology and translation to development programs, and contributing to disease biomarker plans. Maintain very good understanding of disease pathophysiology, disease subtypes and clinical management.
* Collaborates with functions to ensure uniform, aligned operational approach (eg harmonizing study documents, ES, protocols, etc), as relevant, within a project, ensures leadership, builds consensus, coordinates action plans with other development colleagues and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to CSO and TA Heads, as relevant and shares relevant information within development and beyond (project teams, etc.).
* Provide operational expertise to project clinical sub team, as needed.
* Supports the drafting of the extended synopsis of studies and subsequent protocol that he/she will be responsible for, and contribute to the clinical development plans (CDP), review of Investigator’s brochure, the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans by…