Clinical Research Director, Rare Diseases

Job title: Clinical Research Director - Rare Diseases Location: Cambridge, MA / Morristown, NJ About The Job Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions. The Clinical Research Director (CRD), Rare Diseases Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this Therapeutic Area (TA). The CRD is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge and lead clinical study development in alignment with the asset scientific and business strategy. The role will support developing innovative therapies, particularly with an initial focus in the pulmonary space. The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives. Main Responsibilities Create clinical development strategy and plans for one or more assets Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing Advance the clinical development plan through internal management review Lead a clinical sub team to design clinical studies and to create study protocols Execute the clinical development plan in close collaboration with clinical operations Advance scientific and clinical knowledge in rare diseases Incorporate new trial, scientific and digital methodologies Pro-actively progress study execution Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations Review documents supporting clinical development such as Investigators brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews) Serve as a medical expert and provide strategic input to early-stage programs Collaborate with external experts, key opinion leaders, and investigators to advance clinical research Represent Sanofi at scientific conferences and regulatory meetings Scientific And Technical Expertise Has and maintains deep scientific, technical and clinical expertise in the therapeutic area Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders On Clinical Development, The CRD Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes Assessment of the Clinical benefit risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team Provides clinical input to the Target Product Profile Adjusts and updates the clinical strategy when necessary according to the project progression and information available Contributes to the life cycle management strategy for the project whenever appropriate The CRD Is Representative For Clinical Development at the Project Team in meetings with Regulatory Agencies in Steering Committees (SC) and Data Monitoring Committees (DMC) at the Benefit Risk Assessment Committee at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent) The CRD Generates Documents Generates the Clinical Development Plan Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD) Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist Reviews and when appropriate approves the committees charters Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety) and other sections whenever appropriate Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate In charge of the medical/clinical assessment of license-in opportunities About You Experience / Skills: MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia) Have experience in novel approaches to translational medicine Demonstrate problem solving skills #J-18808-Ljbffr BioSpace