Clinical Research Director, Rare Diseases

Role Overview

• 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 (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

Requirements

• 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 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
• 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.

Tech Stack

• Google Cloud Platform

Benefits

• health insurance
• prevention and wellness programs
• at least 14 weeks’ gender-neutral parental leave
• thought out rewards package