Associate Director, Senior Clinical Program Manager
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
• Provides either leadership to, and management of one or more clinical programs within or across a designated Therapeutic Area (TA) or is a leader within a function that supports the delivery of the portfolio. Fully accountable for all deliverables to support the TAs. These functions include Study Operations, Business Operations and Compliance.
• Ensures all activities that support the TA model are successfully planned, implemented and completed in accordance with the Company strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Negotiates or supports the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Drives ownership of all deliverables through effective oversight and governance of the vendors.
• At a study level, responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Department Heads and clinical teams.
• Develops or supports the development of the processes, systems (e.g. eTMF) and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Manages internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities.
• Drives a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality.
• Accountable for developing, coaching, mentoring, retaining, motivating and inspiring individuals in their group.
• Bachelor degree or equivalent. Life science, nursing, pharmacy, or other health/medical related area preferred. Post graduate qualifications preferred.
• 10+ years relevant clinical research experience with additional experience in functional areas within the pharmaceutical industry.
• Solid understanding of the drug development process, and specifically each step within the clinical trial process.
• Experience overseeing global clinical trials (pharmaceutical or research institute).
• Budget forecasting and management;
• Excellent vendor relationship management skills;
• Thorough knowledge of ICH guidelines/GCP and its applicability of all stages of clinical development process.
• Proven leadership and global Clinical Operations experience is essential.