Senior Clinical Research Director, Rare Disease

Job title: Senior Clinical Research Director, Rare Disease

Location:Cambridge, MA / Morristown, NJ

About The Job

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, youll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

Position Overview

The Senior Clinical Research Director (sCRD), 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 sCRD 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 strategic clinical lead and medical spokesperson within the Global Project Team, Protocol Review Committee and Executive Leadership
• Contribute to biomarker identification and provide due diligence support for business development opportunities
  
  
  

Scientific Leadership

• Maintain deep expertise in internal medicine, metabolic diseases, nephrology 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

• Lead 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 Clinical Research Directors and 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: 10 years in drug development, or 10 years pharmaceutical/biotech industry 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.