Telix Pharmaceuticals Limited

Director

• Oversee process development and clinical production of radiolabeled monoclonal antibodies and conjugates.
• Guide late-phase development and commercialization strategy.
• Manage a team of bioprocess and bioconjugation scientists and engineers.
• Ensure readiness for scale-up and manufacturing.
• Ensure Biologics deliverables comply with GMP requirements across multiple regions.
• Engage in cross-functional program matrix teams by providing options analysis and program timeline input.
• Ensure appropriate source documentation to support regulatory filings.

Director, Biologics

Compliance

• Authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections)
• Plan, prepare/revise eCTD Module 2.3 & Module 3 documents
• Ensure Module 3 documentation is planned, tracked, clearly written
• Stay current and interpret evolving CMC regulatory requirements
• Collaborate with internal stakeholders for planning and authoring of CMC regulatory scope and content
• Provide regulatory assessments for manufacturing changes
• Identify potential CMC regulatory risks and suggest mitigation plans

Senior Manager, Global Regulatory Affairs – CMC

• Authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections)
• Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
• Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
• Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
• Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
• Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
• Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.

Manager, Global Regulatory Affairs – CMC

Supply Chain

• Provides transactional support to the logistics team, ensuring that materials, equipment, and supplies are shipped, received, and documented accurately and on time.
• Prepare shipping documentation, including bills of lading, customs forms, and courier paperwork.
• Track inbound and outbound shipments, updating logs, databases, internal and external customer.
• 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 payment to vendors.

Logistics Coordinator

• Author/write CMC specific regulatory dossiers for radiopharmaceutical and biopharmaceutical products
• Plan, prepare/revise eCTD Module 2.3 & 3 documents for various submissions
• Ensure Module 3 documentation is clearly written and compliant with regulations
• Stay current on evolving CMC regulatory requirements and guidelines
• Collaborate with internal stakeholders for regulatory scope and content planning
• Provide assessments for manufacturing changes and develop post-approval supplements
• Identify CMC regulatory risks and suggest mitigation plans

• Responsible for authoring/writing CMC specific regulatory dossiers (3.2.S and 3.2.P sections) towards the development and commercialization of radiopharmaceutical and biopharmaceutical products.
• Develop ICH aligned CMC/Technical portions of global regulatory submissions that are high-quality, fit for purpose, and prepared in a timely manner across for early to late stage and post-approval programs.
• Plan, prepare/revise eCTD Module 2.3 & Module 3 documents for INDs, IMPDQs, NDAs, BLAs, MAAs, CTAs, post-approval supplements and variation submissions, ensuring accuracy and completeness.
• Ensure Module 3 documentation is planned, tracked, clearly written, with the use of regulatory domain systems (Veeva) and processes.
• Stay current and interpret evolving CMC regulatory requirements and guidelines such as ICH, US FDA CFRs, EMA Directives and Annexes. Ensure CMC documentation and data are compliant with regulations.
• Collaborate with internal stakeholders, including Quality Assurance, CMC/Manufacturing, and preclinical teams for planning and authoring of CMC regulatory scope and content.
• Provide regulatory assessments for manufacturing changes, including site transfers, scale-up activities, and process changes. Conduct comparability assessments and develop post-approval supplements as needed.
• Identify potential CMC regulatory risks and suggest mitigation plans to proactively manage issues.

• Demonstrate core strengths in supplier evaluation and selection, monitoring, and development
• Provide strategic vision and process for maintaining the lifecycle management of the GxP supplier qualification process
• Interface with key business partners to foster and maintain external supplier relationships
• Identify key processes to monitor performance of suppliers
• Provide risk inputs to compliance and Quality leadership based on supplier quality activities
• Drives the team to recognize and address systemic quality at external sites and with strategic partners in order to drive improvements and to mitigate risk
• Recommend risk mitigation options to leadership and verify their effectiveness
• Maintain and improve upon the Master Control Supplier Quality and where applicable Audit Module and own the ongoing maintenance of program outputs for Supplier Quality
• Coordinate with Manufacturing and other key business partners to maintain a lifecycle approach to supplier and strategic partner relationships
• Lead the management of the master supplier list for the entire company
• Leads cross-functional teams in Quality improvement initiatives

Associate Director – Supplier Quality

Account Manager

• Play a pivotal role in driving sales and maintaining strong relationships with clients within your assigned territory.
• Identify and pursue new business opportunities within the assigned territory.
• Develop and implement strategic sales plans to achieve sales targets.
• Conduct market research to stay informed about industry trends and competitor activities.
• Cultivate and maintain strong relationships with existing clients.
• Provide excellent customer service, addressing client inquiries and concerns promptly.
• Collaborate with cross-functional teams to ensure customer satisfaction and resolve issues.
• Stay up-to-date with the features and benefits of our radiopharmaceutical products.
• Conduct product presentations and training sessions for clients.
• Prepare regular sales reports and updates for management.
• Analyze sales data to identify areas for improvement and growth opportunities.
• Ensure compliance with all regulatory and company policies.
• Keep abreast of changes in industry regulations and communicate updates to relevant stakeholders.

Territory Account Manager

• Prepare and maintain supply documentation, including shipment records, packing lists, and tracking logs.
• Support the setup and maintenance of inventory databases and trial supply management systems (IRT, ERP, or internal tools).
• Support order entry and communication with manufacturers to produce IMP’s.
• Assist with labeling and packaging coordination activities, under supervision.
• Track and file batch records, temperature logs, regulatory compliance, and other documentation as required.
• Communicate with internal teams to provide updates on shipment status or documentation requests.
• Perform data entry, filing, and archiving to support audits and inspections.
• Identify and escalate discrepancies in supply chain records to senior staff.

Clinical Supply Chain Coordinator

Vice President

• Define medical affairs’ strategy and goals in collaboration with executive Americas leadership.
• Oversee operations, budget and tactical execution, maintaining Medical Affairs excellence.
• Advance collaborations with key opinion leaders and execute strategic plans for scientific engagement.
• Lead strategy and tactical execution across assets and manage a team of Medical Directors.
• Accountable for clinical trial recruitment strategies to support on-time development trials and lifecycle management.
• Work closely with internal department stakeholders to provide Medical Affairs input on product development and launch strategies.
• Lead scientific engagement strategy with key opinion leaders, healthcare providers, and professional societies.
• Accelerate recruitment efforts and enhance subject retention at targeted clinical trial sites.

VP, Medical Affairs

Manager

• Establish, implement and maintain quality assurance processes and documented procedures.
• Plan, conduct and report audits and assessments of Good Clinical Practices (GCPs) and Good Pharmacovigilance Practices (GVP).
• Ensure accurate audit documentation from audits.
• Drive inspection preparation activities for regulatory authority inspections.
• Provide quality oversight and compliance support for various study teams.
• Ensure accurate review and investigation of clinical trial related investigations.
• Review processes to identify gaps in standards.
• Collaborate with Clinical Operations to write and revise SOPs.

Manager, Clinical Quality

Program Manager

• Establish the program guidance to support Telix’s network expansion strategy.
• Develop, articulate, and implement program strategy in collaboration with stakeholders.
• Perform comprehensive gap analysis for CDMO in-house capability expansion.
• Manage complex, strategic cross-functional projects.
• Execute transformation programs to maintain and improve business initiatives.
• Establish portfolio level reporting and governance for business inflection points.

Network Expansion Program Director

Affiliate Manager

• Serve as a trusted advisor and strategic partner to senior leadership, proactively identifying P&C needs and developing solutions aligned with business growth, strategic objectives, and competitive market dynamics.
• Execute comprehensive P&C plans, ensuring alignment with corporate vision, particularly in relation to expanding therapeutic and diagnostic pipelines.
• Take part in P&C due diligence processes during acquisitions, identifying potential risks and creating effective integration plans.
• Manage the human capital components of post-acquisition integrations, ensuring cultural alignment, retention of key talent, and harmonization of P&C practices and policies.
• Deliver initiatives aimed at building organizational effectiveness, enhancing culture, employee engagement, and adaptability.
• Support change management efforts associated with organizational growth, acquisitions, restructuring, and scaling operations.
• Provide expert guidance on complex employee relations issues, promoting positive outcomes aligned with organizational values and legal compliance.
• Champion initiatives that foster employee engagement, wellbeing, diversity, equity, and inclusion throughout the organization.
• Ensure the organization's compliance with employment laws, regulations, and best practices, maintaining awareness of regulatory changes.
• Proactively manage employment risks associated with rapid growth, ensuring P&C policies and procedures reflect current legislation and company strategy.
• Oversee performance management processes, ensuring alignment between individual performance objectives and strategic organizational goals.
• Support professional development programs aimed at enhancing employee skills and competencies in alignment with pipeline and business needs.
• Utilize P&C analytics to identify trends, inform decision-making, and drive continuous improvement.
• Develop meaningful P&C reporting frameworks to communicate key insights to stakeholders and senior leadership effectively.

P&C Business Partner

Sales

• Drive and achieve annual U.S. revenue, delivering the sales plan on a quarterly basis.
• Motivate and direct a team of U.S. Sales AVP’s, applying effective organizational planning and leadership development to enhance employee engagement, accountability, productivity.
• Ensure development of successors for key positions and promotion of high potential talent.
• Collaborate and work cross functionally with peers and colleagues to achieve overall corporate objectives and create an environment of an America’s team.
• Partner with the VP of Marketing in the formulation, interpretation, and implementation of national sales strategies to address issues and opportunities within the US.
• Lead the creation of U.S. incentive compensation plans aligned to the brand's commercial objectives
• Drive sales excellence with focused efforts to increase sales force effectiveness and sales growth exceeding sales targets.
• Lead Telix sales education by developing and executing world class training programs. Exemplify Company’s leadership values of Integrity, Accountability, Extraordinary Customer Service and Quality.

National VP of Sales

• Develop relationships with strategically important partners within assigned networks
• Leverages project management expertise to guide the efforts and coordinate resources to creatively integrate and provide solutions to maximize market potential
• Identify and develop new business opportunities
• Create an environment of collaboration, uniting cross functional teams around common goals for our specialty network strategically important partnerships
• Develop, execute, and lead rolling multi-year multi-faceted strategies to acquire and retain customers
• Ensure all financial matrix and performance exceed corporate goals
• Develop in-depth knowledge including key competitors, terminology, technology, trends, challenges through network relationships and other sources to continuously increase market knowledge, and proactively initiate change to address changing market condition

Specialty Networks Director

Medical writer

• Lead the compilation, writing, and editing of high-quality regulatory documents and reports including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments
• Organize, analyze, and interpret scientific and statistical data
• Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly
• Work with colleagues, physicians, clinical scientists, and statisticians to complete projects in a timely manner
• Collaborate with project teams to respond to health authority questions and requests
• Develop and update SOPs, processes, templates, style guides, and manuals as needed
• Maintain knowledge to enable ongoing execution of function as medical writing expert and of the Telix clinical development pipeline

Medical Writer

Clinical Research

• Define and drive the clinical development plans for Fibroblast Activation Protein (FAP) imaging assets, ensuring alignment with Telix’s broader asset strategy and commercial objectives.
• Partner closely with Global Program Heads, Regulatory Affairs, Medical Affairs, and Translational Medicine to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of diverse stakeholders.
• Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements.
• Lead the creation and review of essential clinical documentation—including informed consent forms, imaging charters, study manuals, and regulatory dossiers—in collaboration with medical writers and cross-functional teams.
• Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs).
• Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle.
• Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights.
• Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility.

Global Clinical Lead – Clinical Scientist

General Counsel

• Telix is a radiopharmaceutical company; the Director, Employee Relations & Legal Advisory provides expert guidance on employment matters across Telix’s global footprint.
• Leads internal investigations (including whistleblower matters) and supervises workplace investigations.
• Manages employment-related disputes, litigation, and regulatory engagements across jurisdictions; liaises with external counsel.
• Advises on employment contracts, remuneration structures, equity, and related documentation to ensure compliance.
• Develops and maintains global workplace policies and governance frameworks; supports training and capability-building on employment law and compliance.
• Works with Risk, Compliance, and P&C to align governance frameworks and risk controls.
• Requires JD, 7+ years of experience in employment law; strong investigative experience; ability to counsel senior leaders.
• Has working knowledge of global employment laws in US, Canada, UK, EU, Australia, Japan.

Director, Employee Relations & Legal Advisory

• The Director, Radiochemistry leads the development, validation, and technical transfer of manufacturing and QC procedures for the company’s clinical-stage radiopharmaceutical assets.\n• This role sets the vision and strategy for the radiochemistry function, ensuring alignment with GMP requirements across multiple regions and readiness for commercialization.\n• The Director manages a team of radiochemists, oversees external partnerships with CMOs, and integrates radiochemistry activities within broader program timelines to support progression to commercial readiness.\n• Oversees development, validation, and optimization of manufacturing and QC processes for radiopharmaceuticals, ensuring GMP compliance across regions.\n• Ensures documentation aligns with the Quality Management System and regulatory requirements.\n• Partners with asset program managers, quality, regulatory, manufacturing, and supply chain teams to align project timelines and technical deliverables.\n• Contributes to regulatory submissions (CMC sections) for INDs, NDAs, BLAs, and international equivalents; supports scale-up for commercial supply.\n• Drives project management through established timelines; develops SOPs, protocols, and reports; drives continuous improvement in radiochemistry.