Lead the development of the Abbreviated Protocol and Protocol development.
Represents the clinical function on Clinical Study Teams and other teams as appropriate.
Provides input into the Translational Medicine Plan that defines the biomarker strategy and other aspects to increase the knowledge about the pathway and effects of the drug.
Ensure that all development activities are targeted towards timely achievement.
Interacts with opinion leaders and external consultants.
Ensures clinical data meets all necessary regulatory standards.
Supports registrations, label submissions and modifications.
Requirements
Medical Doctor with hematology/ transplant clinical expertise preferred.
At least 2 years’ experience in pharmaceutical drug development or clinical research.
Proven record of scientific achievement as evidenced by presentations and publications in peer-reviewed journals and/or successful completion of major clinical studies or submissions is a plus.
Strong scientific and academic background with deep understanding of the disease.
Clinical research or pharmaceutical experience medicine experience in the immunology/hematology/transplant field.
Knowledge of drug development and in immunology/ hematology/ transplant.
Good networking ability in cross-cultural environment.
Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization.
Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
Fluent in English (verbal and written communication).