Executive Medical Director/SERM Head driving clinical safety and pharmacovigilance strategy for Oncology. Leading global teams to ensure highest standards of patient safety with focus on regulatory compliance.
AS
Hybrid Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology
Posted 8 minutes ago
About the role
- 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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