Senior Clinical Scientist

About the Role

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, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

This hybrid position is based in our King of Prussia, PA or Glattbrugg, Switzerland office and requires onsite presence three days a week. Reporting to a Global Clinical Scientist Lead, you will support multifunctional clinical projects in the Cardiovascular-Renal Therapeutic Area.

Responsibilities

• 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 the scientific data analysis and interpretation and help write clinical study reports, internal and external scientific meeting presentations, and publications.
• Support the medical monitoring and oversight of individual clinical studies with an 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/issues requiring medical oversight are brought to the attention of the Medical Monitor.
• Manage the 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 a minimum of 5 years’ experience in the biotechnology or pharmaceutical industry (or biomedical research organization) required; OR Advanced degree (Master’s, PhD) with relevant clinical focus and minimum 3 years’ experience.
• Knowledge in the 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.
• The ability to work collaboratively in a matrix environment is necessary.
• 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop, and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms—plasma fractionation, recombinant protein technology, and cell and gene therapy—to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

Benefits

For more information on CSL benefits, visit How CSL Supports Your Well-being.