Director, Clinical Portfolio Execution

Social network you want to login/join with: Client: CSL Location: King of Prussia PA, Marburg Germany, or Bern Switzerland (Hybrid role) Job Category: Other Job Reference: 9a314a52d7f4 Job Views: 10 Posted: 21.01.2025 Expiry Date: 07.03.2025 Job Description: CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director of Clinical Portfolio Execution? You will have multiple direct reports and will report to the Senior Director of Clinical Portfolio Execution. Responsibilities: Establish and manage standards and processes for main study operations activities (e.g., clinical trial support, clinops human biological sample management). Facilitate global resourcing for clinical portfolio execution roles to support the Head, CPE in ensuring appropriate resource allocation aligned with project priorities, including demand planning and utilization across all programs. Utilize lessons learned from prior study conduct, site visits, audits, and inspections to develop and implement process improvements. Collaborate with Operational Excellence and Clinical Compliance to ensure CSL expectations adhere to ICH GCP guidelines and industry best practices. Lead CPE capability building by supporting onboarding and ensuring harmonization of practice at study level. Set-up and interface with Functional Service providers for study delivery activities. Ensure oversight of vendor activities including FSO and contribute to training FSP staff on CSL expectations. Responsible for quality practices, management monitoring, control documents development, improvement support, and training related to Study Delivery roles. Experience: A Bachelor’s degree in Science or Pharmacy. 12 or more years of relevant clinical research (or related) experience in the pharmaceutical industry. An understanding of the drug development process, 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 employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. #J-18808-Ljbffr