Clinical Operations

• Develop, own, and continuously refine engagement strategies for assigned clinical programs and studies
• Establish and lead cross-functional, program/study-specific Engagement Teams
• Develop and drive engagement plans across the full study lifecycle, from protocol concept and feasibility through execution and close-out
• Serve as the strategic voice of clinical sites within CSL
• Translate site feedback, operational data, and external intelligence into recommendations for feasibility, site selection, recruitment, retention, study execution, and site experience
• Identify risks, barriers, and opportunities early and challenge assumptions and processes
• Align stakeholders across functions and geographies and embed site engagement priorities into study decisions
• Coordinate consistent site engagement across CSL functions
• Identify opportunities to simplify processes, reduce site burden, improve communication, quality, efficiency, timelines, and cost
• Capture and share lessons learned and site insights
• Build and maintain relationships with institutions, investigators, and partner sites
• Understand investigator and site needs, capabilities, challenges, and expectations
• Engage proactively with sites regarding operational trends, barriers, opportunities, and external developments
• Establish feedback mechanisms and communication pathways between sites and CSL
• Champion the site perspective while balancing investigator, study team, patient, and business needs

Associate Director, Clinical Operations – Site Engagement Lead

Clinical Research

• Contribute to the scientific development of clinical development programs and individual studies within the Hematology therapeutic area
• Provide scientific and clinical development input for the safe, efficient, timely, high-quality and compliant execution of assigned programs
• Author and contribute to program- and study-level documents and training materials, including clinical development plans, investigator brochures, protocols, eCRFs, ICFs, study reference manuals and investigator trainings
• Contribute to medical monitoring oversight strategies and implement them to ensure patient safety oversight and data integrity, including ongoing blinded-data review
• May lead development of a Clinical Development Program
• Contribute to authorship and review of manuscripts, conference abstracts and related materials
• Collaborate with internal and external cross-functional stakeholders to translate clinical development strategy and protocols into operational deliverables
• Contribute to scientific analysis and interpretation of clinical data
• Write clinical study reports, scientific meeting presentations, peer-reviewed publications and regulatory submission documents
• Manage processes and liaisons supporting external study oversight committees, including steering, independent data monitoring and adjudication committees

Principal Clinical Scientist, Clinical Development – Hematology

Financial Planning and Analysis

• Consolidate budgets and forecasts across the R&D organisation
• Support planning presentations and resolve issues as they arise
• Analyse R&D expenses by function, account, FTE and major expenditure during budget and forecast cycles
• Work with Business Partners to explain spend and variance drivers
• Act as global owner of the R&D financial planning system, including cost centre hierarchies, active GL accounts, user security, system issues and user support
• Report actual performance against budget and forecast
• Support reporting throughout each planning cycle
• Identify improved reports, retire obsolete reports and contribute to Seqirus FP&A improvement initiatives
• Handle ad hoc analyses and data requests
• Provide back-up to the Business Partner team on planning requirements
• Consolidate month-end results, forecasts, budgets and strategic plan submissions to Group Finance and internal customers

R&D Analyst, FP&A

Scientist

• Develop and implement global CMC regulatory strategies for product development programs, clinical trial applications, marketing applications, and post-approval changes
• Coordinate the preparation, review, and maintenance of CMC regulatory documentation for global submissions
• Ensure regulatory dossiers remain accurate, current, and compliant throughout the product lifecycle
• Partner with cross-functional technical teams to assess manufacturing, facility, equipment, and process changes and determine regulatory impact
• Prepare and review regulatory content for marketing applications, clinical trial applications, lifecycle variations, and responses to health authority questions
• Provide regulatory input into development projects, product quality reviews, risk assessments, and change management activities
• Interpret evolving global regulatory requirements and assess their impact on products and development programs
• Support inspection readiness activities and contribute to continuous improvement of regulatory processes
• Act as a key regulatory partner within cross-functional project teams, providing CMC expertise and strategic guidance
• Report to the relevant Associate Director, Regulatory Affairs

GRA CMC Scientist

Director

• Lead forecasting programs centered around decision analytics for the CSL Hematology portfolio
• Serve as the direct point of contact for forecasting needs of commercial development and Brand/Marketing leads for pipeline and inline assets
• Own assumptions and inputs for short-term forecasts and budget planning
• Act as subject matter expert for end-to-end long-range planning in Hematology
• Manage projects and initiatives supporting the Short Term Forecasting Center of Excellence
• Investigate and answer key business questions globally, influencing R&D and clinical programs, guiding asset strategy, and contributing to go/no-go decisions
• Develop and manage comprehensive long-term forecasting models for global therapeutic areas
• Collaborate with Hematology therapeutic area leaders, R&D PST/GPLs, commercial teams, and corporate finance
• Integrate forecasting insights into annual long-range planning and strategic initiatives
• Collaborate with International and US I&A teams on commercial inputs and assumptions for short-term forecasts and budget planning
• Present forecast scenarios and recommendations to senior leadership and stakeholders
• Provide strategic guidance on market trends, competitive landscapes, and emerging therapeutic opportunities
• Oversee sales data analysis, market research, and external benchmarking
• Support Forecasting COE functions including BD&L, three-year forecasting, and Portfolio/Decision Analytics
• Lead long-range planning, including three-year forecasts, four-to-ten-year volume forecasts, scenario modeling, alignment with global/regional and pricing teams, and forecast submission
• Monitor industry trends, regulatory changes, and forecasting methodology advancements
• Mentor and manage forecasters, contractors, and offshore resources delivering long-term strategic volume and revenue forecasting projects

Associate Director, Strategic Forecasting, Portfolio Analytics

Procurement

• Implement the global IFM strategy across all sites through structured processes and industry best standards
• Lead the external service provider ecosystem and governance
• Define and ensure delivery against SLAs, KPIs, and compliance standards
• Drive cost, service quality, and operational performance
• Act as escalation point for critical operational and supplier issues
• Manage supplier relationships with chosen Global IFM Partners and ensure service delivery meets expectations
• Seek continuous improvement and outstanding hard and soft services, including digitalization innovations
• Ensure Global IFM Partners follow contractual obligations, scope of work, and KPIs
• Ensure global standardization across IFM services wherever possible
• Collaborate with Facility Heads across CSL locations and senior stakeholders
• Foster operational efficiency and eliminate non-value-added activities
• Complete other duties assigned by senior management

Senior Regional Facilities Manager – Vendor Contract Management

• Set strategic direction and priorities as a member of the Global Omnichannel & Digital Strategy Leadership team
• Co-create a cohesive omnichannel engagement strategy with international Marketing and regions across the full product portfolio
• Set the long-term roadmap for omnichannel and commercial excellence tools, systems, and frameworks
• Translate senior leadership priorities across Marketing, Medical, and Commercial into actionable omnichannel plans
• Advise Marketing, Medical, and Commercial heads
• Advocate for local and regional needs with global enablement functions
• Build, lead, mentor, and grow a cross-functional team of senior specialists
• Foster learning, professional development, continuous improvement, innovation, and responsiveness
• Oversee rollout and adoption of systems, tools, processes, and frameworks relevant to omnichannel engagement
• Ensure integration of the right content, channel, and timing
• Design, map, and optimize customer journeys for different segments, ensuring coherent cross-channel touchpoints and KPI focus on ROI
• Apply transformation and change management
• Manage the budget, allocate resources optimally, and manage vendor relationships

Senior Director, Omnichannel Engagement – International

• Develop and implement market access strategies for the assigned therapeutic area
• Partner with Medical Affairs, Marketing, and other cross-functional teams to embed market access considerations in brand strategy and execution
• Lead preparation, submission, and renewal of pricing and reimbursement and health technology assessment dossiers
• Monitor payer regulations, policy developments, and economic evidence across key markets
• Identify opportunities and risks and develop proactive response plans
• Lead development and periodic updates of the Global Value Dossier
• Guide country teams through submissions, negotiations, and interactions with authorities
• Develop and refine payer value propositions and health economic models
• Support lifecycle evidence generation and pricing strategy optimization
• Provide market access insights for forecasting and long-range planning, including payer policy analysis and risk assessment

Director, Global Market Access – Inline Haematology

• Lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management
• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions with regional teams
• Serve as primary regulatory liaison with technical experts and support GMP inspections and inspection readiness
• Interpret regulatory guidelines and requirements, prepare impact assessments, and contribute to process improvements
• Provide technical guidance to the organization
• Maintain relevant parts of regulatory dossiers
• Prepare, revise, and review Module 2.3, Module 3, facility and equipment information, and related documents for registrations and lifecycle submissions
• Author dossier narratives and other regulatory CMC documentation
• Provide responses to CMC-related Health Authority questions
• Compile and review CMC information for CTAs, INDs, Scientific Advice Meetings, Briefing Books, and IBs
• Support regulatory assessments and execution of CMC changes
• Prepare and review CMC information for tenders, PSURs, DSURs, CCDS/product information, and promotional materials
• Contribute to annual product quality reviews and risk assessments
• Participate in Regulatory Affairs Strategy Teams and relevant CMC Regulatory Sub-Teams
• Represent Global Regulatory Affairs in CMC project teams
• Develop and implement global CMC regulatory strategies
• Interface with technical expert departments for project planning, technical documentation, and CMC regulatory questions
• Evaluate technical and scientific CMC information, perform gap analyses, and propose risk-remediation strategies
• Support scheduling and prioritization of CMC-related submissions

Research Scientist

• Serve as the senior pathogen safety scientific expert and primary interface for the assigned site
• Independently assess and resolve complex pathogen safety matters throughout the product lifecycle
• Provide expertise for risk assessments, deviations, changes, product complaints, pharmacovigilance investigations, contamination control strategies, audits, inspections, and regulatory requests
• Partner with Operations, Quality, Regulatory, MS&T, and other functions to provide scientific recommendations and drive resolution
• Evaluate emerging pathogens and assess potential impact to products and operations
• Influence decisions and drive alignment across functions and sites without direct authority
• Contribute to global Pathogen Safety initiatives, standards, best practices, and knowledge sharing
• Provide scientific coaching, technical guidance, and pathogen safety training
• Support continuous improvement of pathogen safety processes, risk assessments, and tools
• Ensure activities meet applicable regulatory requirements and internal quality standards
• Serve as the senior scientific interface for pathogen safety at the Holly Springs, NC or Melbourne, Australia site and across broader Operations

Senior Principal Scientist, Pathogen Safety

• Lead all scientific elements of clinical studies from protocol development through study execution to a final clinical study report
• Write and/or take responsibility for study protocols, clinical study reports, and other critical study documents
• Manage day-to-day working relationships with CROs alongside the clinical operations lead under a full-outsource operating model
• Collaborate with cross-functional study teams
• Contribute to the scientific interpretation of clinical data and supporting documentation
• Build working relationships across the wider team, including colleagues based in the US and Australia
• Act as the scientific and operational anchor between the program team and outsourced delivery partners
• Prepare regulatory submissions of study results, where applicable

Principal Clinical Scientist

Translator

• Act as the hands-on clinical subject matter expert and internal champion for one or more immunology disease areas
• Work directly with bench scientists to translate mechanistic understanding of immune pathology into actionable therapeutic hypotheses and target identification strategies
• Prioritize therapeutic targets and build clinical development plans with the research team
• Monitor competitive landscapes, emerging science, and unmet medical needs across assigned disease areas
• Represent CSL Behring at scientific conferences, advisory boards, and KOL meetings
• Build and maintain networks of thought leaders, clinical investigators, and academic collaborators
• Progress assets from ideation through first-in-disease designation
• Lead or co-lead target and asset evaluations, reviewing preclinical and clinical data packages and mechanism-of-action assessments
• Partner on IND-enabling studies, proof-of-concept study designs, and Phase 1/1b protocol development
• Define disease-relevant biomarkers, pharmacodynamic readouts, and patient stratification strategies
• Partner with the Research Therapeutic Area Lead, RPLs, and Immunology core team to prioritize therapeutic targets and maintain the immunology portfolio
• Support immunology in-licensing and partnering opportunities through clinical and scientific due diligence
• Contribute to Target Product Profiles, integrated development plans, and portfolio reviews
• Provide disease area expertise to regulatory submissions, clinical study reports, and scientific communications

Senior Director, Physician Scientist – Immunology, Translational Medicine

Medical Science Liaison

• Build and maintain trusted relationships with healthcare professionals, researchers, professional associations, and key external experts
• Serve as the primary scientific point of contact for healthcare professionals and external stakeholders
• Conduct scientific exchanges and provide timely, accurate responses to medical information requests
• Lead and support advisory boards, scientific meetings, congresses, and educational initiatives
• Develop and execute engagement plans for key external experts and support speaker development activities
• Gather, analyze, and communicate medical insights from the field to inform strategic decision making
• Support clinical trial feasibility assessments, investigator-initiated studies, and evidence generation activities
• Maintain up-to-date knowledge of assigned therapeutic areas, pipeline developments, and competitive landscape
• Collaborate with Medical Affairs, Commercial, Market Access, Clinical Development, and other teams
• Contribute to product launch preparation and lifecycle management activities across the Nordic region
• Ensure activities comply with company policies, compliance requirements, and applicable regulations
• Approximately 80% customer-facing activity
• Report directly to the Head of Medical Affairs Nordics

Associate Director, Clinical Operations – Site Engagement Lead

Principal Clinical Scientist, Clinical Development – Hematology

R&D Analyst, FP&A

GRA CMC Scientist

Associate Director, Strategic Forecasting, Portfolio Analytics

GRA CMC Scientist

Senior Regional Facilities Manager – Vendor Contract Management

Senior Director, Omnichannel Engagement – International

Director, Global Market Access – Inline Haematology

GRA CMC Scientist

Senior Principal Scientist, Pathogen Safety

Principal Clinical Scientist

Senior Director, Physician Scientist – Immunology, Translational Medicine

Medical Science Liaison, MSL