Telix Pharmaceuticals Limited

General

• Plan, coordinate, and deliver CMC strategies, plans, and deliverables for radiopharmaceutical drug candidates from pivotal Phase 3 hand-off through filing readiness, NDA/MAA/BLA submissions, and commercial lifecycle management
• Represent the CMC team on global matrix teams for assigned projects
• Facilitate and lead internal CMC project teams across technical CMC, Supply Chain, Logistics, Validation, Quality, Clinical Operations, and Regulatory
• Establish and maintain CMC project dashboards, timelines, and budgets
• Track deliverables, initiate purchase-order requests, manage out-of-budget requests, approve invoices, and integrate CMC plans into overall project plans
• Identify CMC risks and mitigation strategies and communicate risks and issues to project teams and senior management
• Provide senior management updates on project status, timelines, risks, issues, KPIs, and forecasts
• Lead CDMO/CMO vendor selection and manage relationships with contract manufacturing partners
• Develop and maintain integrated project plans with internal Telix teams and external CDMO/CMO partners
• Plan hand-offs from development to commercial and lifecycle management
• Facilitate team meetings using project-management best practices and tools
• Maintain meeting agendas, minutes, decision logs, task lists, and risk analyses
• Identify process gaps and implement solutions
• Plan program and commercial budgets with Supply Chain, Program Management, and Finance
• Drive change controls for complex CMC activities, including regional launches, labeling changes, and filing-related process improvements

CMC Program Lead – Illuccix, Gozellix

Clinical Operations

• Serve as the sponsor operational lead for assigned clinical trials
• Lead cross-functional study teams across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Safety, Clinical Supply, Quality, Legal, Finance, and external partners
• Provide sponsor oversight of CROs, vendors, and external partners
• Develop and manage study plans, timelines, risk-management plans, communication plans, monitoring oversight plans, recruitment plans, and other operational plans
• Oversee country and site feasibility, site selection, study start-up, regulatory and ethics submissions, site activation, enrollment readiness, and site performance
• Monitor milestones, enrollment targets, budgets, forecasts, risks, and deliverables; develop mitigation strategies and escalate issues
• Manage study budgets, forecasts, purchase orders, invoices, accruals, change orders, and vendor/site financial oversight
• Develop and provide sponsor input into study documents, including protocols, informed consent forms, study manuals, monitoring plans, vendor plans, training materials, newsletters, and operational guidance
• Ensure quality oversight and inspection readiness through TMF/eTMF completeness, protocol deviation oversight, issue management, audit responses, CAPA follow-up, and compliance
• Support patient recruitment and retention strategies and remove operational barriers
• Prepare and communicate study updates, dashboards, metrics, risks, decisions, and mitigation plans
• Lead study team meetings, vendor governance meetings, risk reviews, lessons learned, and operational decision-making forums
• Represent Clinical Operations in investigator meetings, vendor meetings, conferences, audits, inspections, and governance discussions

Senior Clinical Project Manager

Compliance

• Lead the creation, revision, review, agreement, and maintenance of Investigational Medicinal Product (IMP) and Calibration Labeling
• Collaborate with Regulatory Affairs, Clinical Operations, Quality, Contract Research Organizations, Contract Manufacturing Organizations, translation vendors, artwork vendors, and packaging vendors
• Ensure label content reflects approved protocol requirements, product characteristics, storage conditions, and country-specific requirements
• Ensure compliance with local and regional regulations and internal policies across the United States, European Union, United Kingdom, Australia, Canada, Asia-Pacific, and other participating countries
• Provide labeling expertise during protocol development, clinical study start-up, amendments, and country expansion
• Coordinate translation activities and verification of multilingual labeling content
• Coordinate artwork review and approval in the compliance system
• Manage version control and change management for IMP documentation
• Support IMP labeling submissions or notifications where required
• Evaluate new regulatory requirements and industry trends and assess impacts on studies
• Support regulatory inspections and audits with IMP documentation and subject matter expertise
• Serve as regulatory point of contact for IMP labeling, independently resolving issues and escalating complex matters
• Maintain efficient labeling processes using standardized templates, checklists, and workflows
• Identify process improvements, best practices, and tools
• Assist with other clinical or commercial labeling activities and special projects

Manager, Regulatory Affairs – Clinical Labeling

Supply Chain

• Prepare shipping documentation, including bills of lading, customs forms, and courier paperwork
• Track inbound and outbound shipments and update logs, databases, and customers
• File and archive delivery receipts, invoices, and compliance documentation
• Communicate with couriers and freight providers to confirm pick-ups, deliveries, and schedules
• Assist with routine audits of shipping records and documentation
• Escalate shipment delays, discrepancies, or damaged goods to senior staff
• Audit and reconcile invoices with shipment records to confirm fulfillment and authorize vendor payment
• Oversee daily logistics operations and international shipments of radiopharmaceutical products and related materials
• Coordinate transportation with carriers, freight forwarders, customs brokers, and distribution partners
• Monitor shipments in transit and address delays, exceptions, and service disruptions
• Serve as the primary escalation point for critical logistics issues affecting product delivery and patient schedules
• Prepare export/import and hazardous materials shipping documentation
• Coordinate shipment schedules with manufacturing, packaging, and customer delivery requirements

Logistics Coordinator

• Coordinate the procurement, storage, and distribution of clinical/commercial supplies, including investigational products, lab kits, and other materials
• Maintain inventory levels and manage stock to prevent shortages or overages
• Develop and implement supply chain strategies to optimize efficiency and cost-effectiveness
• Establish and maintain relationships with suppliers and vendors
• Monitor vendor performance and address issues or discrepancies
• Arrange shipment and delivery of clinical/commercial supplies to various sites while ensuring regulatory compliance and timelines
• Coordinate with logistics providers for timely and secure transportation of materials
• Ensure compliance with regulatory guidelines and standards, including GMP and GDP
• Maintain accurate documentation and records for audits
• Collaborate with operational teams, project managers, and stakeholders on study requirements and timelines
• Provide regular supply chain status updates and address issues or concerns
• Identify process improvements and implement best practices
• Stay updated on industry trends and advancements in clinical trial supply chain management
• Perform other supply chain-related duties as assigned

Clinical Supply Chain Specialist

Clinical Research

• Ensure the integrity, accuracy, and compliance of clinical trial data with study and regulatory requirements, SOPs, and CDISC data standards
• Oversee data quality for Telix clinical trials
• Ensure EDC development meets study requirements
• Oversee data cleaning activities and manage external data transfers
• Lead data management activities for assigned clinical trials from study start-up through database lock and study close-out
• Optimize data collection, flow, and access across EDC and non-EDC sources
• Act as primary data management subject matter expert for assigned trials
• Oversee EDC build activities, including DMPs, data review plans, specifications, UAT, and eCRF completion guidelines
• Oversee data entry, cleaning activities, and eTMF data management documentation
• Liaise with external vendors regarding timelines, deliverables, and data transfers
• Assist with review of data-related deliverables and development/review of protocols and SAPs
• Support audits, inspections, study kick-off meetings, and internal Clinical Data Management initiatives
• Ensure compliance with GCP, CDISC standards, and applicable regulations

Clinical Data Manager

Account Manager

• Drive sales growth and strengthen client relationships within the designated region.
• Identify, qualify, and secure new business opportunities within the assigned territory.
• Develop and execute strategic sales plans to meet or exceed territory goals.
• Conduct market analysis covering industry trends, emerging technologies, and competitive activities.
• Build and maintain long-term relationships with key clients and stakeholders.
• Provide customer service by addressing inquiries, concerns, and product needs.
• Collaborate with internal teams to ensure client satisfaction and seamless service delivery.
• Maintain deep knowledge of radiopharmaceutical product features, benefits, and clinical value.
• Deliver product presentations, demonstrations, and training sessions to healthcare professionals.
• Prepare sales reports, forecasts, and performance updates for management.
• Record activities and customer information in Salesforce.com.
• Analyze sales data to identify growth opportunities and performance improvements.
• Follow company policies, procedures, and regulatory guidelines.
• Monitor industry regulations and communicate relevant updates to stakeholders.

Territory Account Manager

Operations

• Serve as the primary intake owner for pricing-related requests and validate submissions
• Manage Business Operations ticketing intake from the commercial field, including categorization, prioritization, and routing
• Prepare and organize inputs for Pricing Committee review
• Coordinate with stakeholders to gather missing information and resolve inconsistencies
• Track Pricing Committee decisions and communicate outcomes and next steps
• Coordinate operational approvals through execution, including contracts, amendments, and system updates
• Partner with Sales, Finance, Legal, Distribution, and Contracting teams to ensure seamless handoffs
• Track active requests, identify bottlenecks, and resolve delays
• Ensure accurate downstream execution of pricing tables, system configurations, and documentation
• Maintain centralized tracking of pricing, contracting, and operational requests
• Provide stakeholders with updates on request status, timelines, and risks
• Develop and maintain reporting or dashboards for volume, turnaround times, and bottlenecks
• Validate data across requests, contracts, and system updates
• Identify discrepancies or risks and support compliance and governance standards
• Identify workflow inefficiencies and recommend improvements
• Support development and enforcement of SOPs
• Reduce manual coordination through process design and system utilization
• Improve turnaround time, accuracy, and execution quality

Commercial Operations Specialist

Director

• Lead, develop, and manage the national Theranostics Specialist team
• Establish the strategic vision, operating model, priorities, and field engagement standards for the Theranostics Specialist function
• Develop performance metrics, dashboards, and business review processes
• Align Theranostics Specialist resources with priority accounts, launch needs, and business objectives
• Lead national execution of site activation, site optimization, customer education, and workflow support
• Oversee onboarding of imaging sites and integration of Telix radiopharmaceuticals into commercial workflows
• Lead protocol standardization, scanner settings, workflow efficiency, image quality support, and site readiness
• Develop and maintain a national training framework covering onboarding, certification readiness, product knowledge, disease-state education, workflow support, and compliant customer engagement
• Partner with Sales, Marketing, Medical, Strategic Accounts, Market Access, Operations, Training, and Compliance
• Lead cross-functional projects improving launch execution, site readiness, customer experience, and commercial performance
• Establish processes for field insights, customer feedback, workflow challenges, and competitive intelligence
• Ensure activities comply with pharmaceutical regulations, corporate policies, approved materials, and ethical guidelines

Director, Theranostics Adoption & Enablement

General Counsel

• Lead Telix's legal operations, technology enablement, process optimization, and contracting infrastructure function
• Own legal intake/routing, matter management, contract playbooks, template libraries, knowledge management, and business self-service tools
• Lead AI-enabled legal workflows, agent design, prompt libraries, and AI-assisted contract review/drafting with human oversight and privacy/security controls
• Translate legal operations requirements into system specifications, user stories, workflows, and integration requirements
• Collaborate with Information Technology and vendors through requirements, design, testing, user acceptance testing, and production rollout
• Own legal operations metrics and KPI reporting, including contract cycle time, outside-counsel spend, contracting throughput, self-service adoption, and satisfaction metrics
• Implement and manage e-billing, matter taxonomy, outside-counsel guidelines, spend reporting, and budget forecasting
• Lead change-management and organizational-adoption programs, including communications, training, feedback loops, and adoption tracking
• Build scalable contracting infrastructure and improve high-volume commercial and procurement contracting processes
• Manage legal technology vendors, budgets, business cases, and return-on-investment models
• Manage and develop the Legal Operations Specialist, United States
• Coordinate cross-functional legal operations with the Australia-based Legal Governance & Operations Specialist
• Partner with Procurement, Information Technology, Finance, Commercial Operations, and business stakeholders
• Support contract negotiation and commercial contracting for procurement and operational matters
• Own the legal enablement strategy and define adoption benchmarks and change-management plans

Assistant Director, Legal Transformation – Enablement

Executive Assistant

• Support the annual Board and Committee program, including coordinating agendas, board papers, minutes, resolutions, director induction, board evaluation logistics, and governance administration
• Assist the Head of Corporate Governance and Group General Counsel in advising the Board, Chair, Chief Executive Officer, Chief Financial Officer, and senior leadership on corporate governance matters, directors' duties, and governance best practices
• Help maintain and continuously improve the corporate governance framework, including Board and committee charters, delegation authorities, policies, and governance guidelines
• Coordinate Australian Securities Exchange compliance, Australian Securities and Investments Commission filings, continuous disclosure, listing rule calendars, securities dealing policies, directors' interests, Annual General Meeting preparation, proxy/shareholder materials, and share registry/depositary relationships
• Coordinate with United States securities counsel on NASDAQ foreign private issuer obligations, Securities and Exchange Commission filings, and United States governance requirements
• Coordinate Governance Specialists across Australia and the United States and liaise with external governance advisers and subsidiary governance providers
• Support subsidiary governance, entity management across jurisdictions, and governance of joint ventures and related entities