Clinical Portfolio Execution Director
vor 1 Tag
Clinical Portfolio Execution Director
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. We are committed to delivering medicines that improve the lives of people with rare and serious medical conditions.
We are seeking a highly experienced Clinical Portfolio Execution Director to join our team. As a key member of our Clinical Portfolio Execution team, you will be responsible for establishing and managing standards and processes for main study operations activities.
Key Responsibilities- Establish and manage standards and processes for main study operations activities, including clinical trial support and human biological sample management.
- Facilitate global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate and resource allocation aligned with project priorities.
- Utilize lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements.
- Lead CPE capability building by supporting onboarding and ensuring harmonization of practice at study level.
- Set-up and make the interface with any Functional Service provider for study delivery activities.
- Bachelor's degree in Science or Pharmacy.
- 12 or more years of relevant clinical research experience in the pharmaceutical industry.
- Understanding of the drug development process and specifically, each step within the clinical trial process.
- Experience in study management, clinical-ops, human biological sample management and related process development.
- Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
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