Director

• Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
• Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
• Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
• Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
• Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA)
• Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
• Manage outsourcing operations or work with internal statistical programmers within the responsible program.
• Ensure timeliness and quality of deliverables by CRO/FSP.
• Support or lead improvement initiatives within the department, organization and/or pharma industry.
• Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.

Associate Director, Biostatistics

• Develop and evolve an enterprise talent strategy aligned to pipeline priorities, product lifecycle needs, and transformation initiatives
• Translate business and portfolio strategy into actionable talent priorities and investments
• Establish enterprise frameworks and governance for talent management across scientific, technical, and commercial populations
• Integrate talent, culture, and leadership expectations to support innovation and patient impact
• Monitor external talent and industry trends in biopharma and life sciences
• Define and design the enterprise approach for identifying and segmenting high-potential and mission-critical talent
• Lead differentiated development strategies for scientific, technical, and enterprise leadership talent
• Enable cross-functional and cross-geography mobility (e.g., R&D ↔ Commercial ↔ Operations)
• Partner with leadership and learning to build targeted accelerated development experiences into the HiPo Learning programs / pathways
• Design and govern a robust succession planning process for executive (SD+) and business-critical roles
• Ensure depth and breadth of leadership pipelines for SD+ roles, critical roles and GLG-1 roles and work across key stakeholders to understand & develop internal and external pipeline strategies
• Support HR/Talent Partners to drive rigor, objectivity, and diversity in succession decisions
• Lead enterprise workforce planning integrating pipeline scenarios, product launches, and global market needs
• Partner with Finance, Talent Acquisition and business leaders on demand forecasting and scenario planning
• Identify capability gaps and inform build/buy/borrow/bot/bounce strategies

Senior Director, Talent Strategy – Management

People Operations

• Analyze workforce, talent, and engagement data to identify trends, patterns, and insights
• Produce and maintain standard and ad-hoc reports, dashboards, and metrics
• Ensure accuracy, consistency, and reliability of data across people systems
• Translate data into clear insights and observations
• Provide analytical support to workforce planning, listening, and enterprise demand planning activities
• Support internal and external benchmarking, trend monitoring, and comparative analysis
• Work with HR systems and data owners to support data extraction, validation, and reporting processes
• Identify opportunities to improve data, reporting, and analytics processes

Senior Analyst, People Analytics & Insights

Research Scientist

• Provide scientific and operational expertise to support pathogen safety activities across manufacturing, technical operations, and product lifecycle management.
• Plan and execute scientific work packages supporting pathogen safety activities across the product lifecycle.
• Conduct scientific risk assessments related to manufacturing changes, deviations, product complaints, pharmacovigilance investigations, and other operational matters.
• Author and review technical documents, annual reports, regulatory submissions, and responses to health authority requests.
• Support internal and external inspections, audits, and regulatory commitments.
• Provide scientific and technical support to pathogen safety projects and cross-functional initiatives.
• Collaborate with Manufacturing Sciences & Technology (MS&T), Technical Operations, Quality, Regulatory Affairs, and other stakeholders to assess and prioritize pathogen safety requests.
• Identify and implement opportunities to improve workflows, processes, and knowledge-sharing practices.

Principal Scientist, Pathogen Safety

Software Engineer

• Responsible for providing hands-on support and technical guidance on clinical study teams
• Development of study and ad hoc output, including ADaM datasets, tables, figures, and listings output and/or QC of requested output
• Collaborates with the study statistician to design data structure and specifications for adhoc and study deliverables
• Leads the production and validation efforts for the designed output; may include oversight of work by CROs
• Supports the review of related deliverables when provided by CROs
• Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables

Senior Programmer

Executive Assistant

• Provide comprehensive administrative and organizational support to leadership within Tech Ops
• Manage complex calendars, coordinating meetings and events
• Handle domestic and international travel arrangements
• Ensure meeting readiness, manage individual expense reporting
• Support special projects as needed
• Serve as a liaison with internal and external stakeholders globally

Architect

• Own and drive the global job architecture framework, ensuring consistency and transparency in job leveling across all businesses.
• Oversee job leveling for all businesses globally, maintaining consistency and transparency in job structures.
• Own and manage the global Job Catalog, ensuring it is current, comprehensive, and accurately reflects the work performed across the enterprise.
• Partner with TR Partners, business leaders, and HRBPs to support organizational design initiatives and ensure job structures reflect evolving business needs.
• Oversee processes for market survey matching, ensuring jobs and levels are accurately mapped to external benchmarks.
• Collaborate with Total Rewards partners to analyze market data and guide compensation decisions.
• Establish and maintain governance processes for job architecture, leveling, and catalog management.
• Ensure compliance with internal policies and external regulations related to job structures and compensation.
• Work closely with Total Rewards partners, HRBPs, and business leaders to drive alignment and adoption of job architecture frameworks.
• Monitor trends and best practices in career architecture, organizational design, and compensation.

Senior Manager, Career Architecture Lead

Project Manager

• Provide strategic Project Management leadership for external innovation activities
• Partner with Search teams to plan and manage projects related to scouting and initial assessment of external opportunities
• Maintain visibility of Search pipeline and ensure alignment with corporate strategy
• Partner with Search lead and project manage early due diligence assessments of potential in-licensing or acquisition opportunities
• Develop and manage integrated project plans
• Ensure seamless transition to Development PM for Stage 2 Due diligence or continue through Stage 2 Due Diligence
• Execute governance processes for timely, high-quality decisions on external opportunities
• Build strong relationships with senior stakeholders across R&D, BD, Legal and Finance
• Drive continuous improvement and innovation, enhancing processes and tools

Director, Project Management, Search & Evaluation

• Partners with cross-functional teams to develop the pub plans, as needed and accountable for ensuring execution of all publication plans across all TAs
• Accountable for publication management system activities across all TAs
• Lead a publications team and hold accountability for smooth and compliant execution of pubs across all TAs
• Accountable for all training activities for all of MA with respect to publication process
• Accountable for the audits and governance of all publications. Liaise with legal and compliance, as needed
• Accountable for all metrics and analytics for pubs for senior leadership
• Accountable to represent Global publications in all strategic meetings across all TAs
• Accountable for vendor management of all publications across all TAs ensuring tracking of budget for all pubs and ensuring preferred vendor utilization for all pubs activities
• Follow and stay abreast of updates to publication-related guidelines including but not limited to International Committee of Medical Journal Editors (ICJME), Good Publication Practice (GPP), CONSORT Guidelines, American Medical Association (AMA) Manual of Style, and Council of Biology Editors.
• Represent the organization at appropriate publication forums to elevate enterprise profile
• Proactively identify operational challenges and suggest opportunities and solutions for improving operational efficiency

Director, Global Medical Publications

• Leads the Global Labeling strategy function within Global Labeling, Advertising & Promotion.
• Provides labeling guidance / perspective to respective governance bodies.
• Coaches/mentors Global Labeling Sr. Strategists in strategic thinking, technical and leadership attributes.
• Ensures the optimal development / implementation of processes and supports revisions to these processes for continuous improvement.
• Engages cross-functionally with key stakeholders in Global Regulatory Affairs and Safety, Clinical Research, Commercial Development, Medical Affairs and Market Access.
• Establishes a high performing, global culture and organizational model that facilitates the creation and maintenance of scientifically-sound, regulatory-compliant core and local labeling.
• Develops global labeling strategies to enable business objectives while optimizing product benefit/risk information for users and prescribers.
• Contributes and directs strategic initiatives targeting business, regulatory requirements and clinical needs.
• Manages the Global Labeling Committee for the product portfolio.
• Ensures labeling adheres to company SOPs and regulatory requirements.
• Represents CSL at industry associations, conferences and health authorities.

Senior Director, Global Labeling Strategy

Auditor

• Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
• Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
• Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
• Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
• Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Auditor – GCP

Account Manager

• Establish and maintain effective external relationships for the manufacture of gene therapy and recombinant products.
• Work with key CSL functions in selection of external partners.
• Support vendor selection, technology transfer, technical dossier writing and ongoing technical support.
• Identify external partnering needs for the gene therapy portfolio.
• Support drafting of agreements with external partners.
• Responsible for process and analytical technology transfer oversight.
• Provide technical SMEs for process/analytical development, manufacturing and QC testing.

Director, External Partnerships – Technology Transfer

• Provides scientific leadership for nonclinical due diligence supporting CSL’s in‑licensing, acquisitions, and strategic collaborations.
• Leads operational execution of nonclinical due diligence for assigned opportunities.
• Acts as hands‑on scientific integrator, translating expert input into clear risk narratives.
• Integrates input from Toxicology, PK/QSP, Nonclinical Pharmacology, and external experts.
• Prepares high‑quality DD reports, executive summaries, and risk tables for governance review.
• Mentors junior contributors and matrix team members as appropriate.

Director, Nonclinical Due Diligence – External Innovation

• Head an integrated Clinical Pharmacology capability in support of R&D programs
• Oversee and develop innovative globally applicable clinical pharmacology strategy
• Ensure the use of innovative analytical methods
• Provide senior clinical pharmacology representation at internal R&D review meetings