CSL Limited

Senior Clinical Scientist

CSL Limited$110K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent with 5+ years in biotech/pharmaceutical industry; or advanced degree (Master's, PhD) with 3+ years experience.
  • Familiarity with pharmaceutical drug development processes, particularly in biotherapeutics.
  • Proficiency in EDC systems for data collection and analysis.
  • Ability to work collaboratively in a matrix organization.
  • Experience managing relationships with CROs and AROs.

Responsibilities

  • Develop and implement individual clinical studies as per development plan.
  • Provide scientific input for study execution to ensure compliance and quality.
  • Create high-quality regulatory documents and training materials.
  • Contribute to the design and review of eCRF, SAP, and TLFs.
  • Assist in analyzing clinical data and writing reports and publications.
  • Monitor individual clinical studies focusing on subject safety and data integrity.
  • Manage collaboration with external oversight committees.

Benefits

  • Hybrid work model with onsite requirements three days a week.
  • Opportunities for collaboration with a global team of experts.
  • Engagement in a diverse range of cardiovascular-renal therapeutic projects.
Full Job Description
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

About CSL Limited

CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
Learn more about CSL Limited
Size
25,000 employees
Industry
Founded
1904
NASDAQ

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