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-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Sanofi 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.
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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.