Global Head of Clinical Operations at CSL

King of Prussia, Pennsylvania, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

Experience leading global clinical operations across therapeutic areas including Vaccines, Immunology & Transplant, Immunoglobulins, Hematology, Cardiovascular & Renal
Proven ability to manage R&D investments over $400M in clinical studies
Expertise in collaborating with strategic partner CROs for optimized clinical trials
Strong leadership skills to create and nurture a high-performing team culture and develop talent
Capability to drive growth focused on 6 key pillars: delivering development pipeline, operational excellence, innovation in trial planning/execution, CRO collaboration, optimizing healthcare worker/study participant interactions, and business/patient-focused mindset
Knowledge of global functions in study delivery: feasibility, start-up, clinical data management, study management, site relationship management & monitoring, study document management, clinical compliance, patient-focused trial transformation
Strategic visioning and roadmap development aligned with R&D and corporate goals
Financial acumen for budgeting, forecasting, and resource prioritization
Regulatory compliance expertise

Responsibilities

Provide overall operational leadership to all clinical programs, ensuring effective management of R&D investment over $400M
Actively manage internal and external activities to deliver top quartile cycle times in study execution and address operational challenges
Monitor and manage study progress/challenges through operational governance; represent Clinical Operations in internal meetings/forums
Manage departmental/program performance via key metrics and mitigation strategies
Identify/deploy cross-program synergies and innovation opportunities
Assess operating procedures and drive quality improvements
Strategically partner with internal/external stakeholders to manage risks and achieve study delivery objectives
Create strategic vision/roadmaps aligned with R&D/corporate aspirations
Provide guidance/coaching to TA Clinical Operations Leads for strategic input into Clinical Development Plans
Lead teams to develop strategies for efficient delivery per company objectives
Create vision for future clinical trials and approaches to optimize patient/provider experiences
Partner with R&D Portfolio/Business Excellence on digital transformation vision/business cases
Develop/manage department/clinical trial budgets with Business Operations/partners for efficient resource use and forecasting
Lead prioritization of work/resources across clinical programs
Ensure adequate resourcing of Clinical Programs with internal/external support
Create/optimize scalable resourcing strategy combining internal/external resources
Ensure regulatory compliance

Skills

Clinical Trial Management

CRO Oversight

Study Feasibility

Study Start-up

Clinical Data Management

Site Relationship Management

Clinical Monitoring

Study Document Management

Clinical Compliance

Patient-Focused Trials

Portfolio Management

Operational Excellence

CSL

Develops biotherapies and influenza vaccines

About CSL

CSL develops and delivers biotherapies and influenza vaccines, focusing on rare and serious diseases. Their products include plasma-derived and recombinant therapies, which are created through extensive research and development. CSL serves a wide range of clients, including healthcare providers and governments, across the Americas, Asia Pacific, and Europe. What sets CSL apart from competitors is its comprehensive portfolio and commitment to addressing rare diseases, alongside a strong emphasis on diversity and inclusion within its workforce. The company's goal is to save lives and protect health through its innovative therapies and vaccines.

Parkville, AustraliaHeadquarters

1916Year Founded

$2,628.7MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Emerging synthetic biomaterials may reduce demand for traditional plasma therapies.

Jumar Bioincubator could increase local competition in the biotech sector.

CSL may need to adapt to the rising effectiveness of cell-based influenza vaccines.

Differentiation

CSL offers the broadest range of plasma-derived and recombinant therapies globally.

CSL's self-amplifying mRNA COVID-19 vaccine provides longer immunity at lower doses.

CSL's MF59® adjuvant enhances immune response, crucial for pandemic preparedness.

Upsides

CSL's garadacimab could be the first monthly treatment for hereditary angioedema.

CSL's cell-based influenza vaccine shows higher effectiveness over egg-based vaccines.

CSL's gene therapy HEMGENIX® offers a one-time treatment for haemophilia B.

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