Clinical Research Director, Rare Disease

Description: The Clinical Research Director (CRD), Rare Disease Therapeutic Area, is responsible for contributing to the creation and execution of the clinical development strategy for assigned projects in this Therapeutic Area (TA). The CRD is expected to contribute to the growth of the Rare Disease TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities by challenging ?the status quo?.Principal Duties & Responsibilities:Based upon an in-depth scientific understanding and extensive clinical experience, the CRD is responsible for:Drafting the extended synopsis of studies that he/she will be responsible for, and contribute to the clinical development plans (CDP), the clinical sections of integrated development plans (IDP), and overseeing the execution of such plans by the respective operational units in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs). He/she will also represent the project in relevant teams and the protocol review committee and review and comment the Investigator?s brochure.Assisted by related Sanofi Genzyme 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.Defends the CDP in front of internal management committees, regulatory agencies, and alliance partners, where applicable. The CRD 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 CRD will be requested to contribute expertise to specific tasks such as the evaluation of potential in-licensing candidates.Scientific and technical Expertise:This position requires a strong scientific and clinical foundation in internal medicine. It requires knowledge in metabolism as well as in all aspects of drug development. Strong leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.Has and maintains deep scientific, technical and clinical expertise in internal medicine and related areasUnderstands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interestCritically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive productsMaintains visibility within the Rare Disease Therapeutic Area to maintain credibility with internal and external stakeholdersEnsures that all development activities are proactively planned and targeted towards timely achievementInteracts with opinion leaders and consultants.Owns (in collaboration with Project Team), the ?Extended synopses? for individual studies CDP and clinical sections of IDP and is responsible Clinician for the implementation of clinical strategyInfluences the definition of the product value proposition (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 projectsComplex Problem Solving: As CDPs are sophisticated documents that require the ability to integrate highly complex scientific, medical and operational information, strong scientific, medical and analytical skills are required.An innovative and open-minded approach to problem solving is critical to arrive at the optimal solution for complex development challenges. Regulatory responsibilities:Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and projectEnsures clinical data meets all necessary regulatory standardsSupports registrations, label submissions and modificationsParticipates in Advisory Committee preparationScientific data dissemination: Ensures timely submission and dissemination of clinical dataSupports the planning of advisory board meetingsEstablishes and maintains appropriate collaborations with knowledge expertsIn addition to the above activities the CRD must ensure that all activities of the Global Project Team are conducted in compliance with current regulations, laws and guidance from FDA, EMA, and CHMP, as well as with Sanofi?s policies and procedures.Basic Qualifications:Medical Doctor, PhD desirable.Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME)More than 5 years of clinical or scientific, or more than >10 years industry, experience within drug developmentStrong scientific and academic background with deep understanding of the therapeutic areaClinical research experience in rare disease drug development preferredKnowledge of drug development preferredGood networking ability in cross-cultural environmentStrong interpersonal, communication, presentation, and negotiation skills across all levels of the organizationPerformance oriented with ability to work along agreed timelines and a focus on strategy and executionOutstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skillsFluent in English (verbal and written communication)At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce ? and workplace ? which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.