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AS
Hybrid Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology
Posted 2 months ago
About the role
- Senior Medical Director providing medical and scientific input for early phase clinical development in Rheumatology. Collaborating with cross-functional teams and external partners to deliver innovative clinical studies.
Responsibilities
- Provide medical and scientific input to preclinical and clinical stage assets focused on Rheumatology/Clinical Immunology
- Take responsibility for clinical development in cross-functional teams
- Support early phase clinical development activities
- Create overall clinical development plans and clinical study design
- Writing protocols, key study and health authority documentation
- Medical monitoring and ensuring timely delivery of studies
- Collaborate with internal and external partners and clinical research organizations
- Ensure the ethical and scientific integrity of the plans, studies, and product in compliance with GCP
- Provide guidance in the medical strategy and clinical/disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development
- Closely follow medical developments within the autoimmune / inflammatory diseases
Requirements
- Advanced degree in Rheumatology/Clinical Immunology (MD or PhD)
- Minimum of 7 years combined industry or relevant clinical or research experience
- A background working in clinical development
- Experience in Rheumatology or Immunology in a pharmaceutical or biotechnology company including knowledge and experience in the design and execution of clinical trials in diseases such as systemic lupus erythematosus or rheumatoid arthritis
- Understanding of the entire drug development process, including clinical and non-clinical study design and execution
- Thorough understanding of clinical research methodology and biostatistics principles
- Thorough command of FDA, MHRA and ICH GCP guidelines
- Attention to detail, internal drive to generate high-quality work
- Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders
Benefits
- Short-term incentive bonus opportunity
- Eligibility to participate in equity-based long-term incentive program
- Qualified retirement program [401(k) plan]
- Paid vacation and holidays
- Paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage
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