Sr Director, Operational Excellence and Clinical Compliance

The Opportunity

• Reporting to the VP, Clinical Development Operations (CDO), you will lead process and system efficiency and productivity improvements in CDO, an organization that accounts for approximately 1/3 of all R&D expenditure. You will drive a portfolio of change initiatives that facilitate compliant, efficient and participant-focused Clinical Development (CD) delivery. You will define important process gaps, measure current state, assess strategic options for process or system advancement, improve projects, and set up appropriate metrics to track consistency and efficiency of Clinical Development Operations.
• You will also oversee clinical compliance and training functions within CDO, ensuring that clinical operations are conducted according to standard operating procedures (SOP), Good Clinical Practices (GCP) and other applicable regulatory requirements. You will certify systems and training both internally and externally mean CSL trials are inspection ready worldwide. You will ensure training is fit-for-role and enables compliance across all GCP-sensitive roles within CDO.
• You will influence all Therapeutic Areas and Clinical Development Operations functions and is the Chief Operating Officer of the CDO function. You will be a central point for supporting CDO-led strategic planning and innovation through collation, prioritization and management of relevant proposals.

The Role

Oversee Clinical Compliance and Training

• Following evolving global, regional and country level standards for clinical compliance and GCP, is accountable for the development, definition and documentation of clinical processes, measuring and analyzing the compliance, quality and efficiency of the processes and implementing fit for purpose training curricula.

Lead operational data reporting and analysis strategy and methods

• Lead the development of CDO operational reports and dashboards providing real-time, drill down functionality that allows understanding the current state of clinical operations regarding meeting project time, quality and budget milestones.

Lead selection of areas for process improvement based on diagnostics

• Lead the CDO-LT in selection of key performance measures for improvement based on data. Develop and manage framework/standardized processes and tools that promote best practice approach across CDO to manage process improvement in a strategic initiative portfolio.

Expand and guide use of innovation platform to assist and inform innovation strategy

• Develop and maintain an innovation platform for CDO and broader clinical research, using best practices across CSL and industry. Ensure the platform allows relevant R&D leaders to solicit, prioritize, manage, view and track current innovation and improvement initiatives, submit ideas for innovation and manage information around ideas and projects.

Lead program management of innovation and change-based portfolios

• Be a business partner with key leaders while identifying performance improvement opportunities, aligning and prioritizing them directly to business strategy and priorities. This includes building and owning strong business partnerships with key departments (e.g., HR, Finance, IT, Operations Management) and delivering tangible results by deploying problem solving and implementation techniques.

Identify and reduce or eliminate inefficiencies in CDO processes and decision models

• Understand that innovation is not always additive but can be removing or streamlining clinical development tasks that are no longer value added and uses that knowledge to work with stakeholders in assessing the full resource impact of each change initiative implemented.

Ensure best practices in innovation and change management are utilized

• Engage with and leverages external biopharmaceutical organizations to drive innovation and application of best industry practices.

Your skills and experience

• Minimum of a Bachelor's Degree required with preferred focus in a scientific/medical/pharmaceutical discipline, preferably combined with relevant clinical trial experience.
• Extensive understanding of the clinical research and drug development lifecycle
• 10+ years of professional work experience in a Clinical Development/Research environment
• Experience in project management and operational process improvement
• Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives
• Experience working in a global pharmaceutical environment
• Experience managing processes with a continuous improvement and change management approach
• Strong leadership and communication skills with special emphasis on collaboration, influencing and negotiation skills

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.