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
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

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
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.

Clinical Research Director – Rare Diseases

Key skills