Principal Clinical Development Scientist – Biotechnology & Pharmaceuticals

CSL seeks a Principal Clinical Scientist in Clinical Development to lead strategy and execution of global clinical programs for innovative biologics targeting serious and rare diseases. You will design and optimize clinical trial protocols, collaborate with biostatistics, pharmacovigilance, and regulatory teams, and provide scientific leadership from early development through registration. Responsibilities include data interpretation, safety and risk–benefit assessments, authorship of key clinical documents, and representation in health authority interactions. In CSL’s inclusive, patient-focused culture, you’ll mentor junior scientists and partner with global experts to deliver high-quality evidence that advances life-changing therapies worldwide. Lead clinical strategy and execution for global development programs in serious and rare diseases. Design and optimize clinical trial protocols and related study documents. Interpret clinical and safety data, performing risk–benefit assessments for pipeline assets. Author and review key documents including CSRs, IBs, protocols, and regulatory submissions. Collaborate with biostatistics, pharmacovigilance, regulatory, and operations teams to ensure trial quality. Contribute to health authority interactions and responses to regulatory questions. Provide scientific leadership in cross-functional project teams and governance forums. Mentor and develop junior clinical scientists and medical writers. Ensure adherence to GCP, ICH, and global regulatory guidelines across assigned studies. Champion CSL’s patient-focused, values-driven culture and support continuous process improvement. Clinical trial design Clinical data analysis and interpretation GCP and regulatory compliance (FDA/EMA/ICH) Protocol and SAP development Medical writing (CSRs, IBs, submissions) Risk–benefit and safety assessment Cross-functional leadership Vendor and CRO management Biostatistics literacy Oncology/rare disease therapeutic area expertise Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k MD, DO, or PhD in life sciences Board certification in relevant therapeutic area (preferred) GCP certification Clinical research certification (e.g., ACRP, SOCRA)