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Director, Clinical Portfolio Execution - King Of Prussia Pennsylvania
Company: CSL Behring Location: King Of Prussia, Pennsylvania
Posted On: 05/16/2024
Job DescriptionCSL 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? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. You will have multiple direct reports. You will report to the Senior Director of Clinical Portfolio Execution.Responsibilities: - You will 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 and resource allocation aligned with project priorities. In collaboration with Business Operations, includes demand planning and utilization across all programs. Ensure there is a communication strategy laterally and vertically for resource management and utilization.
- 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. Manage framework/standardized tools that enable best practice approach.
- Lead CPE capability building by supporting onboarding. Ensure Harmonization of practice at study level, to ensure consistency, high quality, and efficiency.
- Set-up and make the interface with any Functional Service provider for study delivery activities. Ensure oversight of vendor activities including FSO. May contribute to train FSP staff on CSL expectations.
- Responsible for quality practices, management monitoring, control documents development, improvement support and training related to Study Delivery roles People ManagementExperience
- 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, 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.
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