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, you'll 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 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. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. North America Applicants Only The salary range for this position is: $236,250.00 - $393,750.00 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube