Clinical Research Director, Rare Disease

Job Title: Clinical Research Director, Rare Disease

Location: Cambridge, MA, Morristoen, 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.

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 its 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.