Clinical Portfolio Execution Director
vor 4 Wochen
Position Overview:
CSL Behring is a prominent global biotechnology organization dedicated to enhancing and saving lives. We focus on providing therapies for individuals facing rare and serious health conditions.
With a presence in over 35 countries and approximately 30,000 employees, CSL is committed to developing a diverse array of life-saving treatments for conditions such as hemophilia, primary immune deficiencies, and vaccines for influenza. Our products are also utilized in cardiac surgeries, organ transplants, and burn care. As a leading entity in the protein biotherapeutics sector, CSL Behring aims to deliver innovative biotherapies for critical and often uncommon medical conditions.
Key Responsibilities:
- Establish and oversee standards and procedures for primary study operations activities, including clinical trial support and management of human biological samples.
- Facilitate global resource allocation for clinical portfolio execution roles, ensuring alignment with project priorities and effective communication strategies for resource management.
- Implement process enhancements by leveraging insights from previous studies, site visits, audits, and inspections, while ensuring compliance with ICH GCP guidelines and industry best practices.
- Support capability development within Clinical Portfolio Execution through effective onboarding and harmonization of practices at the study level to ensure consistency and high-quality outcomes.
- Manage interactions with Functional Service Providers for study delivery, ensuring oversight of vendor activities and training on CSL expectations.
- Oversee quality practices, monitoring, and development of control documents related to Study Delivery roles and People Management.
Qualifications:
- A Bachelor's degree in Science or Pharmacy.
- At least 12 years of relevant experience in clinical research or a related field within the pharmaceutical industry.
- Comprehensive understanding of the drug development process, particularly the clinical trial phases.
- Experience in study management, clinical operations, and human biological sample management.
- Familiarity with ICH GCP, FDA GCP Regulations, and EU clinical trial directives.
Our Commitment:
CSL Behring is dedicated to the well-being of our employees and their families. We offer a comprehensive benefits package that supports our employees at every stage of their lives, including health care, financial protection, and resources for personal and professional development.
About CSL Behring:
CSL Behring is a global leader in the development and delivery of high-quality medicines for individuals with rare and serious diseases, providing hope to patients in over 100 countries across various therapeutic areas.
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