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Americas, US-PA, King of Prussia, CSL Behring, United States of America
Onsite
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.
Could you be our next Senior Clinical Scientist? The job is in our King of Prussia, PA or Glattbrugg Switzerland office. This is a hybrid position and is onsite three days a week.
Reporting to a Global Clinical Scientist Lead, you will support multifunctional, clinical projects in the Cardiovascular-Renal Therapeutic Area. You will work with the Program Director and other Clinical Scientists in performing delegated tasks to support the clinical development program as dictated by therapeutic area/ project needs.
The Role
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. regulatory submission documents
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 identification of 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, provide training to the clinical execution team.
Qualifications:
Bachelor's degree, or equivalent with 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), and 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, data interpretation
#LI-HYBRID
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 of 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.