The role of the CRD is to:

Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional repsTake on as necessary the Associate CRD role:Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)Contribute to the Extended synopsis and Protocol for their projectContribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authoritiesProvide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigatorsBe the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data

Key responsibilities include:

Leading the clinical development plan strategies:

Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teamsRaise study or project-level issues to the project headContribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projectsCollaborate with external partners, regulators, and diverse internal stakeholders and collaboratorsEvaluates relevant medical literature and status from competitive products

Lead, Support and oversee the execution of clinical development and studies activities

Review and validate the final protocol and protocol amendmentsReview the ICF WSI and TDFAssisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)Lead the study specific committees (IDMC, steering com, adjudication …) with operational supportCo-Develop the SAP in collaboration with bio statsResponsible for key results preparationDevelop the clinical study reportTake on as necessary the Associate CRD role:Develop the abbreviated protocolDevelop the final protocol and protocol amendmentsMedical support to clinical operation team during the clinical feasibilityReview and provide clinical input across different study documents written subject information, CRF, e-diary, monitoring planMedical support to clinical operations team on study plans: CMP/MRP, DR & DS reviewReview/approve study-related documents (eg vendor specifications for centralized services, CRF, CRF completion guidance, patient diary, etc)Participate in the elaboration of training material and presentations at the investigator meetingsEnsure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with operational support, bio stat and GSOAnswer to medical questions raised by EC/IRBs, sitesSupport CRD trial master file documents readiness and availability, and mandatory trainings linked to the clinical functionCollaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), including but not limited to:feasibility managers for feasibility preparation and validation of feasibility resultsMedical Writers to develop, review and finalize WSIs, study protocols and reportsClinical Scientists, Medical review team and CodingPharmacovigilance (GSO, CME)CTOMs, BiostatisticiansCSU medical advisors for the best knowledge of the study, compound, protocolTA Experts, senior CRDS, global clinical lead, GPHs and medical affairsCROsRegulatory affairsCollaborates with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with 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 the global project head and clinical leadProvide operational expertise to project clinical sub team, as needed

Responsibilities related to regulatory and safety documents and meetings:

Review and/or contribute in the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMPContribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIPEnsures clinical data meets all necessary regulatory standardsParticipates in Advisory Committee preparation

Scientific Data evaluation and authorship: Participate and author manuscripts and abstracts Support the planning of advisory board meetings Establish and maintains appropriate collaborations with knowledge experts Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

Experience

Understanding of pharmaceutical product development and life cycle managementVery good Scientific and medical/clinical expertiseVery good expertise in clinical development and methodology of clinical studiesVery good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agenciesDemonstrated capability to challenge decision and status quo with a risk-management approachAbility to negotiate to ensure operational resources are available for continued clinical conductFluency in written and spoken EnglishVery good teaching skills, demonstrated ability to assist and train othersAbility to work within a matrix modelInternational/ intercultural working skillsOpen-minded to apply new digital solutions

China Specific Requirements:

To lead China clinical development plan with solid knowledge and comprehensive experience on drug development, by engaging CN and global multi-function teams; to represent CN team in GPT and governance review.To be liaison between Sanofi R&D and related medical societies in CN, to lead CN KOL interaction for project and study related issues.To provide clinical direction in CN submission strategy, to lead CN specific clinical topics, documents and dossiers in CTA, NDA and HA interaction.To provide timely clinical support on study level issues in GSD to ensure the success of CN development strategy. To be the primary contact for GPH and GCL for China strategy and issue discussion.

Minimum Level of any Required Qualifications: 

Medical Doctor (MD) is must, Master and Ph.D. is preferred; with 8+ years in pharmaceutical industry; 5+ years in global/clinical drug development; 3+ years in project management:Clinical Physician experience in relevant TA is a plus.Team management skill;

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