Global Head of Clinical Operations

The Position:

The Vice President, Clinical Development Operations will have overall strategic and operational responsibility for the successful execution of the global portfolio of clinical programs across all therapeutic areas: Vaccines; Immunology & Transplant, Immunoglobulins; Hematology; Cardiovascular & Renal.

This position leads the organization to deliver optimized clinical trials, in collaboration with our chosen strategic partner CROs, supporting products that deliver lasting impact to patients’ lives and public health. The VP is responsible for creating and nurturing a strong culture, developing high performing teams and talent.

This leadership role drives growth with a focus on 6 key pillars:
• Delivering the development pipeline
• Ensuring operational excellence
• Innovating across clinical trial planning and execution
• Collaborating with strategic CRO Partners
• Optimizing healthcare worker and study participant interactions
• Operating with a strong business- and patient-focused mindset

The areas of responsibility include global functions involved with study delivery, including engaging the CRO on study level needs, oversight of CRO-delivered trial activities and oversight in the areas of feasibility, start-up, clinical data management, study management; site relationship management & monitoring; study document management; clinical compliance, and patient-focused clinical trial transformation.

Responsibilities:
Clinical Program Operational Leadership
• Provide overall operational leadership to all clinical programs, ensuring the R&D investment over >$400M in clinical studies is effectively managed
• Actively manage activities internally and externally to deliver industry top quartile cycle times in study execution, and in collaboration with Portfolio and Business Excellence, address challenges that are impeding predictable and reliable operational delivery
• Monitor and manage study level progress and challenges through leading operational governance. Represent Clinical Operations at internal governance meetings and leadership forums
• Manage departmental and program performance through key metrics and robust mitigation strategies
• Identify and deploy opportunities for Clinical teams to leverage cross-program synergies and to take advantage of new opportunities to drive innovation in delivery
• Continually assess operating procedures and take action to drive on-going quality improvement
• Strategically partner with key internal and external senior stakeholders to manage operational and departmental risks, as well as ensure study delivery objectives are achieved

Strategic Planning
• Create strategic vision aligned with R&D and CSL corporate strategic aspirations and create relevant roadmaps to achieve them
• Provide guidance and coaching to TA Clinical Operations Leads to ensure strategic operational input into all Clinical Development Plans
• Lead Clinical Development Operations teams to develop strategies to efficiently deliver according to company objectives
• Create vision for clinical trials of the future and develop approaches to connect with healthcare providers for an optimized patient and provider experience
• Partner with R&D Portfolio and Business Excellence to develop digital transformation vision and business cases for long term roadmap

Financial & Resource Management
• In partnership with Business Operations and key partners, develop and manage department budget as well as overall clinical trial delivery budgets to ensure efficient use of internal resources as well as accurate forecasting across the portfolio of studies
• Lead the prioritization of work and resources across all clinical programs
• Ensure all Clinical Programs are adequately resourced with both internal and external support
• Create and optimize a scalable resourcing strategy to support seamless delivery of clinical studies with a combination of internal and external resources

Regulatory Compliance
• Ensure all areas of accountability are compliant with ICH/GCP guidelines as well as other regulatory standards and requirements both internally at CSL and with our strategic CRO partners
• Ensure coordinated relationship with CQA to drive inspection readiness and overall quality of clinical studies

Lead People
• Develop culture that enables successful recruitment and retention of high-quality Clinical Development Operations staff
• Create a culture of high performing teams able to work effectively in a matrixed environment
• Create and encourage a culture of experimentation, innovation and applied learning
• Ensure effective utilization and performance management of staff
• Lead, coach, develop, and retain management team with an emphasis on developing capacity in strategic thinking, operational efficiency and innovation
• Effectively manages resources within a large, complex matrix organization consisting of direct team members, CRO vendors & internal shared services to deliver clinical development strategies

External Relationship Development
• Embed patient focus in all ways of working and ensure patient insights and understanding their lived experience contribute to all development activities
• Interface as a key functional leader with Strategic Externalization to ensure that  CRO relationships are optimized for consistent delivery of contracted services through direct communication with CRO leaders and as an active participant in vendor governance
• In partnership with Portfolio and Business Excellence, drive continuous improvement, cost savings and innovation in all strategic CRO relationships and their interfaces within CSL. Oversee active governance for CRO relationships
• Manage overall approach for cultivating relationships with healthcare providers and study sites globally to enable CSL to be a sponsor of choice for clinical development

Education & Requirements:
• Bachelor’s degree, or equivalent in a scientific/ medical/pharmaceutical/business discipline is essential. Relevant post-graduate qualifications desirable
• Further study or research experience in a CSLB-relevant disease area is highly desirable
• 15+ years of pharmaceutical or biotech drug development experience working in a Clinical Operations environment
• Proven leadership and global Clinical, Data & Business Operations experience is essential
• Direct leadership of clinical trials activities within and outside of the US
• Previous experience building and managing teams for 10+ years
• Proven leadership experience and success with building & developing matrix global teams
• Ability to lead interactions with multiple stakeholder groups and interfaces – for example with Therapeutic Area leaders, R&D functions, Clinical Development Operations leaders, and across the enterprise
• Proven ability to create a vision and operating model, and lead teams across programs to deliver on and to translate strategy into long - term execution plans
• Experience leading large complex cross functional teams as well as external CRO’s

Our Benefits

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.

About CSL Behring

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.

We want CSL to reflect the world around us

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.

Do work that matters at CSL Behring!