Clinical Research Director, Immunology & Inflammation (Rheumatology)

Role Summary

Clinical Research Director, Immunology & Inflammation (Rheumatology) responsible for creating the clinical development plan, aligning with project strategy, and executing with clinical operations. Focus on advancing immunology in rheumatologic diseases and developing innovative therapies for autoimmune and inflammatory diseases.

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 responses 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 of relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies
• Experience/enthusiasm in advancing assets from discovery into clinical development
• Experience in novel approaches to translational medicine
• Deep scientific, technical and clinical knowledge in immunologic/rheumatologic diseases
• Expertise in autoimmune and inflammatory diseases, particularly in rheumatology
• Problem-solving skills
• Understanding of pre-clinical, clinical pharmacology and clinical data relevant to the molecule and therapeutic area
• Strong leadership with ability to influence and collaborate in a matrix environment
• Excellent communication and presentation skills; 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 planning and project management
• Scientific and clinical expertise in immunology and rheumatology
• Regulatory affairs and health authority engagement
• Effective communication and presentation

Education

• MD or MD/PhD in a relevant scientific discipline