CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, CSL is building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The position is based in King of Prussia, PA or Glattbrugg, Switzerland, and is hybrid with onsite work three days a week.
Tasks
- Support multifunctional clinical projects in the Cardiovascular-Renal Therapeutic Area.
- Work with the Program Director and other Clinical Scientists to perform delegated tasks supporting the clinical development program as dictated by therapeutic area and project needs.
- Help develop individual clinical studies according to the clinical development plan within the assigned therapeutic area.
- Provide scientific input for the safe and efficient execution of assigned studies, ensuring the highest quality and full compliance of all outputs.
- Help develop high-quality program and study level documents and training materials aligned with project plans (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings, clinical study report and regulatory submission documents) in compliance with federal regulations, GCP and good medical practice.
- Provide clinical science input into design and review of eCRF, SAP, and TLFs.
- Support scientific data analysis and interpretation and help write clinical study reports, internal and external scientific meeting presentations, and publications.
- Support medical monitoring and oversight of individual clinical studies with emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, including ongoing review of blinded data, use of data visualization tools and programmed reports.
- Identify clinical data trends, issue and resolve corresponding queries, ensure consistency of medical coding and other important data, and identify cases for medical review.
- Ensure all questions and issues requiring medical oversight are brought to the attention of the Medical monitor.
- Manage processes and partnerships required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, clinical events committee).
- Collaborate with internal and external partners to ensure translation of the clinical protocol into operational deliverables, serve as primary contact for protocol guidance, and provide training to the clinical execution team.
Requirements
- Bachelor's degree or equivalent with minimum of 5 years' experience in the biotechnology or pharmaceutical industry (or biomedical research organization); OR advanced degree (Master's, PhD) with relevant clinical focus and minimum 3 years' experience.
- Knowledge in drug development processes for pharmaceuticals with experience in biotherapeutics desirable (e.g. therapeutic proteins, monoclonal antibodies).
- Demonstrated ability to use systems and tools (e.g., EDC systems) for data collection, analysis and reporting.
- Ability to work collaboratively in a matrix environment.
- Experience working with CROs and AROs, including providing oversight.
- Proficient knowledge and technical skills to support study-specific data review, trend identification, and data interpretation.
Benefits
CSL supports employee well-being and fosters inclusion and belonging at the core of its mission. CSL is an Equal Opportunity Employer and provides reasonable accommodation for individuals with disabilities during the application process.
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Über uns
Das Team
Reporting to a Global Clinical Scientist Lead, you will collaborate with the Program Director and other Clinical Scientists within a project-led, agile team environment.