Clinical Research Director - Immunology and Inflammation

Main Responsibilities

• Contributes to the development of the clinical strategy and plan
• Leads 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
• Ensures that all development activities are targeted towards timely achievement (e.g., Abbreviated Protocol and protocol before study start, committees management and centralized monitoring during study, and KRM & CSR preparation at study end)
• Interacts with opinion leaders and external consultants
• Serves as medical monitor for the studies assigned
• Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
• Ensures clinical data meets all necessary regulatory standards
• Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
• Participates in Advisory Committee preparation
• Ensures timely submission and dissemination of clinical data
• Supports the planning of advisory board meetings
• Establishes and maintains appropriate collaborations with knowledge experts

Scientific and Technical Expertise

• Has and maintains deep scientific, technical and clinical expertise in transplant, nephrology, hepatology and/or immunology/inflammation field
• Has a demonstrated track record in clinical development, with Phase 3 experience being an advantage
• Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest – Knowledge on antibody is a plus
• Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
• Maintains visibility within the dermatology field to maintain credibility with internal and external stakeholders

Regulatory Responsibilities

• Represents the Division at key regulatory agency meetings as the medical spokesperson for the studies and project
• Ensures clinical data meets all necessary regulatory standards
• Supports registrations, label submissions and modifications (contributes to IB, DSUR, Briefing Package for Health Authorities)
• Participates in Advisory Committee preparation

Scientific Data Dissemination

• Ensures timely submission and dissemination of clinical data
• Supports the planning of advisory board meetings
• Establishes and maintains appropriate collaborations with knowledge experts

About You

• Medical Doctor with transplant, nephrology, hepatology or immunology clinical expertise preferred
• Minimum 2 years experience in pharmaceutical drug development and/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 in medicine experience in transplant/immunology field
• Knowledge of drug development and in immunology
• 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)