Clinical Research Director, Rare Diseases

About This Role

This role involves developing and executing clinical development strategies for rare disease projects within Sanofi, with an initial focus on the pulmonary space. The Clinical Research Director will lead cross-functional teams, advance scientific and clinical knowledge, and ensure studies comply with internal and external regulations.

Responsibilities

• Create and execute clinical development strategy and plans for one or more assets in Rare Diseases Therapeutic Area
• Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies
• Align clinical development strategy with global project teams and internal partners
• Advance the clinical development plan through internal management review
• Lead a clinical sub-team to design clinical studies and create study protocols
• Execute the clinical development plan in close collaboration with clinical operations
• Advance scientific and clinical knowledge in rare diseases, incorporating new trial, scientific, and digital methodologies
• Oversee the execution of clinical studies in compliance with internal SOPs, GCP, and ICH guidelines
• Review documents supporting clinical development, including Investigator’s brochure and regulatory submissions
• Engage with health authorities and serve as a medical expert, providing 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

Requirements

• MD or MD/PhD in a relevant scientific discipline (preferably pulmonology)
• 2+ years experience in clinical development (pharma, academia, or government agencies)
• Experience/enthusiasm in advancing assets from discovery into clinical development
• Experience in novel approaches to translational medicine
• Demonstrated problem-solving skills
• Deep understanding of pre-clinical, clinical pharmacology, and clinical data relevant to the molecule and therapeutic area
• Strong leadership skills with ability to influence and collaborate in a matrix environment
• Excellent communication and presentation skills

Qualifications

• MD or MD/PhD in a relevant scientific discipline, preferably pulmonology
• At least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies

Nice to Have

• Proven track record of scientific publications and presentations at international conferences

Benefits