Clinical Research Director - Immunology and Inflammation
Clinical Research Director - Immunology and Inflammation
Posted 10 days ago
SENIORITY
Manager
About the role
- Some of the CRD's core job responsibilities include those listed below, as well as all other duties assigned.
- 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
- 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
- Ensure 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
- Serve 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
- 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 medicine 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)
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
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Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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