The Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for dermatology programs.The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.The role of the Senior CRD is to:Act as a mentor for other CRDs and Clinical Scientists on a same project/TACollaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs 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 TA Heads, as relevant and shares relevant information within and beyond Project teams.Take on as necessary the 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 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 dataInteract with other CRDs in the project, Principal CRD, Global Project Head, The PV Rep, Regulatory and other key functional repsMain responsibilities:Internal Governance: Preparation of Documents and Presentations for Internal Governance MeetingsProvide oversight and strategic direction to CRD in preparation for and during health authority meetingsTake on as necessary the CRD role: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 productsAbout youMedical Doctor (MD) required: GP or specialist (dermatology experience optimal), English fluent (spoken and written)Proven experience in the pharmaceutical industry or CRO, previous experience in clinical developmentSanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.#LI#GDAt Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
