Clinical Research Director, Immunology & Inflammation (Rheumatology)

Role Summary

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. Location: Cambridge, MA / Morristown, NJ.

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

Qualifications

• 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

Skills

• Leadership and cross-functional collaboration
• Strategic thinking and program management
• Clinical development and regulatory awareness
• Scientific communication and presentation
• Translational medicine and immunology/rheumatology knowledge
• Problem solving