Clinical Research Director, Immunology & Inflammation (Rheumatology)

Job title : Clinical Research Director in Immunology & Inflammation (Rheumatology) Location : Cambridge, MA / Morristown, NJ About the job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Position Overview : The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in rheumatologic diseases, incorporate new methodologies, and pro-actively progress study execution. The role will focus on developing innovative therapies for autoimmune and inflammatory diseases, with a particular emphasis on rheumatology. We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities :

• Create clinical development strategy and plans for one or more assets
• Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
• Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
• Advance the clinical development plan through internal management review
• Lead a clinical sub team to design clinical studies and to create study protocols
• Execute the clinical development plan in close collaboration with clinical operations
• Advance scientific and clinical knowledge for immunology in rheumatologic diseases
• Incorporate new trial, scientific and digital methodologies
• Pro-actively progress study execution
• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
• Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
• Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)
• Serve as a medical expert and provide strategic input to early-stage programs
• Collaborate with external experts, key opinion leaders, and investigators to advance clinical research
• Represent Sanofi at scientific conferences and regulatory meetings About You Experience / Skills :
• MD or MD / PhD in a relevant scientific discipline with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization
• Experience / enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
• Have experience in novel approaches to translational medicine
• Have and maintain deep scientific, technical and clinical knowledge in immunologic / rheumatologic diseases
• Expertise in autoimmune and inflammatory diseases, particularly in rheumatology
• Demonstrate problem solving skills
• Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
• Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment
• Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences
• Proven track record of scientific publications and presentations at international conferences 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-SA #LI-SA #LI-Onsite #vhd 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. (https : / / benefits.sanofiusallwell.com / fleet / public / index / ba511bf8-5c32-4828-9861-ab985fffab90 / ?cid=sanofi)