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 Principal Scientist? The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week.
You will hold work closely with the CDT Lead and other Clinical Representatives in performing delegated tasks in support of the clinical development program as dictated by therapeutic area/ project needs.
Main Responsibilities:
1 Contribute to the scientific development of clinical programs and individual clinical studies in alignment with the clinical development plan within the assigned therapeutic area.
2 Provide scientific and clinical development input for the safe, efficient, and timely execution of assigned programs, ensuring the highest quality and full compliance of all outputs.
3 Author and/or contribute to the development of program and study level documents and training materials aligned with the scientific strategy (e.g. clinical development plan, IB, protocols, eCRF, ICF, study reference manuals, investigator trainings).
4 Contribute to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents.
5 Define and implement the medical monitoring and oversight strategy of individual clinical studies to ensure the highest level of patient safety and data integrity, including ongoing review of blinded data.
6 Manage the processes and liaisons required to support external study oversight committees (e.g. Steering committee, independent data monitoring committee, adjudication committee).
7 Collaborate with internal and external cross-functional stakeholders to ensure translation of the clinical development strategy and clinical protocol into operational deliverables.
8 Contribute to multidisciplinary working groups to support continuous process improvement as requested.
Qualifications and Experience Requirements:
Bachelor’s degree, or equivalent, in a Science related field is required.
• An advanced degree (MS, PhD) in Science or Allied Health is preferred.
Experience
• 4+ years’ experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization) or equivalent
• At least three years’ experience in clinical research
• In-depth knowledge in the drug development processes for pharmaceuticals (e.g. project management, CMC, non-clinical, clinical, Regulatory Affairs).
• Experience providing oversight to CROs.
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CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
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. Learn more Inclusion and Belonging | CSL.