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Endodontics Limited
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases.
You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Global Clinical Lead is a significant subject matter expert (SME) role that exists within Telix to design, lead and implement the clinical development strategy for the Company’s Therapeutic assets. The Global Clinical Lead will lead the design of therapeutic clinical trials, including but not limited to protocol design, endpoints, eligibility criteria, and statistical plans.
Requirements
of both internal stakeholders and external stakeholders including, but not limited to regulatory authorities, guidelines committees, payors, patient advocacy groups, and relevant business partners. In this role, the Global Clinical Lead will work closely in a matrix organization with the respective Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, Therapeutic Business Unit Head and other relevant cross-functional teams to advance Telix Group’s therapeutic assets towards the clinic. This will be undertaken via a deep working knowledge of the existing and future competitive landscape in relevant cancer therapy areas.
Clinical documentation leadership : 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 Regulatory and scientific contributions : 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) Data integrity and analysis : 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 Stakeholder communication : Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights External engagement and thought leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to infor