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Clinical Portfolio Execution Director

vor 2 Monaten


Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

Position Overview:

CSL Behring, a leader in biotechnology, is dedicated to the mission of enhancing and saving lives. Our commitment extends to millions globally who are affected by rare and serious health conditions. We strive to provide innovative therapies that significantly improve patient outcomes.

With a presence in over 35 countries and a workforce of approximately 30,000, CSL is driven to develop and supply a diverse array of life-saving treatments for conditions such as hemophilia, primary immune deficiencies, and vaccines for influenza. Our therapies are also integral in cardiac surgeries, organ transplants, and burn care. As the parent organization of CSL Behring, CSL Plasma, CSL Seqirus, and CSL Vifor, we are at the forefront of the protein biotherapeutics sector, focused on delivering biotherapies for serious and often rare medical conditions.

Key Responsibilities:

  • Establish and oversee standards and procedures for core 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 in collaboration with Business Operations.
  • Implement process enhancements by leveraging insights from previous studies, site evaluations, audits, and inspections, 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.
  • Coordinate with Functional Service Providers for study delivery activities, ensuring oversight of vendor operations and training on CSL expectations.
  • Manage quality practices, including monitoring, control document development, and training related to Study Delivery roles.

Qualifications:

  • A Bachelor's degree in Science or Pharmacy.
  • A minimum of 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.

Benefits:

CSL Behring offers a comprehensive benefits package for employees working a minimum of 30 hours per week, effective from day one. We prioritize the well-being of our employees and their families, providing resources and benefits that support various life stages. Our offerings include health care, financial protection, mental health resources, and support for charitable contributions.

About CSL Behring:

CSL Behring is recognized globally for its commitment to developing and delivering high-quality medicines for individuals with rare and serious diseases. Our innovative treatments provide hope to patients in over 100 countries, addressing conditions across immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas.