Clinical Research Director, Rare Disease

Job Title: Clinical Research Director, Rare Disease Location: Cambridge, MA, Morristoen, NJ About The Job Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Position Overview The Clinical Research Director (CRD), Rare Disease, is a senior scientific and clinical leader responsible for shaping and executing clinical development strategy for assigned rare disease programs — driving them from early development through registration with a patient-centric focus. The CRD serves as a recognized scientific authority within the Rare Disease TA, championing clinical excellence, challenging conventional approaches, and advancing Sanofi's mission to deliver transformative therapies to underserved patients. Key Responsibilities Clinical Development Strategy & Execution Lead design and authorship of study synopses, CDPs, and clinical sections of IDPs Oversee end-to-end trial execution through cross-functional units, ensuring GCP and regulatory compliance Define and manage timelines, budgets, and risk mitigation strategies with Clinical Operations, Project Management, and Procurement Serve as clinical lead and medical spokesperson within the Global Project Team and Protocol Review Committee Contribute to biomarker identification and provide due diligence support for business development opportunities Scientific Leadership Maintain deep expertise in internal medicine, metabolic diseases, and rare disease biology Integrate preclinical data, clinical pharmacology, and competitive intelligence to inform strategy Champion innovative trial designs — adaptive, natural history, and real-world evidence — appropriate for rare disease contexts Influence product value proposition through evidence-based input on unmet needs and development approaches Regulatory Strategy Represent programs at key regulatory interactions (FDA, EMA, PMDA) as primary medical spokesperson Develop engagement strategies for pre-IND, End-of-Phase meetings, and Advisory Committee preparations Support label development, registration submissions, and post-approval modifications Ensure all activities comply with FDA, EMA, CHMP, ICH guidance and Sanofi policies External Engagement & Dissemination Drive timely publication of clinical data in peer-reviewed journals and at scientific congresses Lead advisory board meetings and maintain strategic relationships with KOLs, patient advocacy organizations, and rare disease consortia Cross-Functional Collaboration Align cross-functional stakeholders around a unified development vision; present CDPs to governance and senior leadership Partner with Medical Affairs, Biostatistics, Translational Medicine, Regulatory, Market Access, and Commercial functions Mentor junior clinical scientists and contribute to talent development within the Rare Disease TA Required Qualifications Education: MD required; MD/PhD strongly preferred; medical degree from LCME-accredited or equivalent institution Experience: 5+ years in drug development in pharmaceutical/biotech industry with experience in clinical development Rare Disease: Demonstrated experience with orphan drug frameworks and small patient population trial design Technical Skills: Expertise in clinical pharmacology, biomarker strategy, benefit-risk assessment, and innovative trial designs Leadership: Proven ability to lead cross-functional global teams without direct authority; strong negotiation and decision-making skills Communication: Exceptional written and verbal English; ability to present to scientific, regulatory, executive, and patient audiences Preferred Qualifications Board certification in metabolic medicine, medical genetics, nephrology, or cardiology Direct experience with lysosomal storage disorders, enzyme replacement therapy, or gene therapy Prior experience as medical spokesperson in FDA/EMA meetings Familiarity with real-world evidence (RWE) in rare disease regulatory submissions Peer-reviewed publication record in the relevant therapeutic area Experience with business development and scientific due diligence 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-craf