Development Scientific Director - Sanofi : Job Details

Development Scientific Director Location: Cambridge, MAAbout the JobAre you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.The Clinical Development Scientist is a key scientific lead for development programs. The role requires a well-organized, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability to deliver on multiple operational tasks.This role will provide clinical scientific expertise for:The clinical studies (except Clinical & Exploratory Pharmacology studies) and/or registries to be carried out by Clinical Sciences & Operations (e.g., 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 individual 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 individual 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 representatives.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Main ResponsibilitiesProvide 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 (e.g., 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: feasibility managers for feasibility preparation and validation of feasibility resultsClinical Research Directors, Clinical Scientists, Medical review team and CodingPharmacovigilance (GSO, CME) regarding safety management and case processingCTOMs, BiostatisticiansCSU medical advisors for the best knowledge of the study, compound, protocolTA Experts, GPHs and medical affairsCROsRegulatory affairsProvide input to the study extended synopsis and protocol based on feasibility pre-assessment, protocol complexity index and assist in determining associated cost.Responsible for supporting the overall supervision/execution of clinical scientific validation/review of study data, including writing or supervision of study-related documents (e.g., medical review plan, guidelines, etc.).May organize/contribute to Investigators' Meetings, Steering Committees, Data Monitoring Committees Meetings, adjudication committees and prepare related material (e.g., charter, presentations).Provide clinical scientific answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team.Secure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function.Review/approve study-related documents (e.g., 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.Collaborate with functions to ensure uniform, aligned operational approaches (e.g., 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 the respective operational units in compliance with SOP, GCP and other regulations.Assisted by related Sanofi functions (e.g., clinical operations, project management, and procurement), responsible for defining timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials.Supports the team with defending the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The individual may provide input into strategies to increase understanding of the mechanism of action of the drug including but not limited to the identification of biomarkers. On an ad hoc basis, the individual will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates.About YouExperience:Understanding of pharmaceutical product development and life cycle management gained through at least 2 years of development and clinical scientific experience.Very good scientific expertise.Very good expertise in clinical development and methodology of clinical studies.Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies.Demonstrated capability to challenge decisions and status quo with a risk-management approach.Ability to negotiate to ensure operational resources are available for continued clinical conduct.Fluency in written and spoken English.Very good teaching skills, demonstrated ability to assist and train others.Ability to work within a matrix model.Minimum Level of any Required Qualifications:PhD in a Life Science or Health Science related field. English fluent (spoken and written).At least 2 years in pharmaceutical industry or CRO, previous experience in clinical development.Why Choose Us?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.#J-18808-Ljbffr