Clinical Research Director, Rare Diseases

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 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 Investigators 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

Scientific and Technical Expertise

• 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 therapeutic area to maintain credibility with internal and external stakeholders

On Clinical Development, the CRD

• Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes
• Assessment of the Clinical benefit risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team
• Provides clinical input to the Target Product Profile
• Adjusts and updates the clinical strategy when necessary according to the project progression and information available
• Contributes to the life cycle management strategy for the project whenever appropriate
• The CRD is representative for Clinical Development:
• at the Project Team
• in meetings with Regulatory Agencies
• in Steering Committees (SC) and Data Monitoring Committees (DMC)
• at the Benefit Risk Assessment Committee
• at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)

About You

• Experience / Skills:
• MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, 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
• 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