Description
CSL Behring is a global biotechnology leader dedicated to saving and improving lives. We develop and deliver medicines for rare and serious medical conditions, with operations in over 35 countries and approximately 30,000 employees worldwide.
Our therapies address disorders such as hemophilia, primary immune deficiencies, and include vaccines to prevent influenza. They are also used in cardiac surgery, organ transplantation, and burn treatment. CSL Behring is part of CSL, which also includes CSL Plasma, CSL Seqirus, and CSL Vifor. We are a leader in the protein biotherapeutics industry, focused on bringing innovative treatments to market.
We are seeking a Director of Clinical Portfolio Execution. This role can be based in King of Prussia, PA, Marburg, Germany, or Bern, Switzerland, and is a hybrid position. The successful candidate will have multiple direct reports and report to the Senior Director of Clinical Portfolio Execution.
Responsibilities:
* Establish and manage standards and processes for main study operations activities, including clinical trial support and biological sample management.
* Facilitate global resourcing for clinical portfolio roles, ensuring appropriate resource allocation aligned with project priorities, demand planning, and utilization.
* Develop and implement process improvements based on lessons learned from study conduct, site visits, audits, and inspections.
* Collaborate with Operational Excellence and Clinical Compliance to ensure adherence to ICH GCP guidelines and industry best practices.
* Lead capability building, onboarding, and harmonization of practices at the study level for consistency and quality.
* Manage interfaces with Functional Service Providers and oversee vendor activities, including training FSP staff on CSL expectations.
* Ensure quality practices, develop control documents, and support training related to Study Delivery roles.
Experience:
* Bachelor’s degree in Science or Pharmacy.
* 12+ years of relevant clinical research experience in the pharmaceutical industry.
* Understanding of the drug development process and clinical trial steps.
* Experience in study management, clinical operations, biological sample management, and process development.
* Knowledge of ICH GCP, FDA GCP Regulations, and EU clinical trials directives.
Our Benefits:
Employees working at least 30 hours per week are eligible for benefits from day one. We offer resources and benefits supporting health, financial protection, and overall wellbeing, tailored to employees' needs at every life stage.
About CSL Behring:
CSL Behring develops and delivers high-quality medicines for rare and serious diseases, serving over 100 countries in areas such as immunology, hematology, cardiovascular, respiratory, and transplant therapies.
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