Clinical Research Director (CRD), Rare Diseases

Role Summary

Clinical Research Director (CRD), Rare Diseases, located in Cambridge, MA or Morristown, NJ, leads the development strategy and execution for assigned projects in the Rare Diseases therapeutic area. Creates the clinical development plan aligned with project strategy, governance endorsement, and close collaboration with clinical operations. Advances scientific and clinical knowledge and leads clinical study development in alignment with asset strategy, with initial focus in the pulmonary space, and contributes to the growth of the Rare Blood Disorders therapeutic area by driving clinical and scientific knowledge and improving operational capabilities.

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 in rare 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 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
• Represent Clinical Development in project governance forums (Project Team, regulatory meetings, Steering Committees, Data Monitoring Committees, BRAC, and Submission Task Force) and provide clinical input on product information
• Generate and maintain key clinical development documents, including the Clinical Development Plan, briefing packages for regulatory meetings, extended synopsis for trials, protocol reviews, and clinical sections of the CTD/Investigator Brochure; coordinate with pharmacovigilance and medical writing; respond to regulatory questions; assess license-in opportunities

Education

• MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years of 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

Qualifications

• Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)
• Experience in novel approaches to translational medicine
• 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

• Has and maintains deep scientific, technical and clinical expertise in the therapeutic area
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
• Maintains visibility within the therapy area to maintain credibility with internal and external stakeholders