Global Clinical Lead
About the role
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. Thereby, the Global Clinical Lead, will ensure the therapeutic programs are founded on sound scientific decision-making and are able to be progressed efficiently and effectively towards commercial realization by generating high quality clinical data to serve the 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.
Key Accountabilities
- Design, lead and implement Clinical Strategy: Define and drive the clinical development plans for Telix’s Therapeutic assets, ensuring alignment with Telix’s broader asset strategy and commercial objectives
- Cross-functional collaboration: Partner closely with Global Program Heads, Clinical Operations, Regulatory Affairs, Medical Affairs, and the Therapeutic Business Unit Head to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of internal and relevant external stakeholders
- Clinical study design and execution: 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
- 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 and reports to internal leadership, external partners, and regulatory agencies