See Yourself at Telix
We are seeking an experienced Global Clinical Lead as part of our Clinical Strategy and Innovation team to lead clinical development of novel imaging assets.
The Global Clinical Lead will ensure the diagnostic programs are founded on sound scientific decision-making and are able to be progressed efficiently and effectively towards commercial realization by generating clinical data to serve the requirements of both internal stakeholders and external stakeholders including, but not limited to regulatory authorities, healthcare professionals, patient groups, guidelines committees, payors, and pharmaceutical and business development collaborators.
The Global Clinical Lead will work closely in a matrix organisation with the respective Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, Business Unit Heads and other relevant cross-functional teams to advance Telix Group's assets in prostate cancer imaging. This will be undertaken via a deep working knowledge of the existing and future competitive landscape.
Key Accountabilities:

• Lead development of clinical development plans for diagnostic assets in solid tumors
• Collaborate with global program heads, regulatory affairs, medical affairs, and translational medicine teams to ensure alignment of clinical trial objectives with overall asset strategy
• Develop clinical study plans from concept to synopsis to full protocol, ensuring alignment with the Company's objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
• Develop – in collaboration with relevant cross-functional teams and medical writers – clinical study documentation including, but not limited to informed consent documents, imaging charters, study manuals and final regulatory dossiers.
• Lead clinical scientific input into documentation including investigator brochures, IMPDs, safety reports (e.g. DSURs, PSURs, and SUSARs), clinical study reports and regulatory documents such as briefing packages, INDs, BLAs, NDAs and MAAs
• Lead the analysis, review, and quality control of clinical data (e.g. study-related, aggregated) including efficacy, safety, and imaging data to ensure accuracy and quality
• Prepare and deliver presentations, proposals, and reports for senior management, partners, and other stakeholders

Education and Experience:

• Medical degree or Ph D required
• Experience in oncology or nuclear medicine is essential
• 5+ years of experience in clinical development
• Early-stage development strongly preferred
• Strong knowledge of clinical trial design, methodology, and regulatory requirements
• Successful leadership and project management of clinical development programs
• Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred

Key Capabilities:

• Willingness to travel domestically and internationally, as needed
• Strong understanding of the nuclear imaging market, products, and technologies
• Excellent negotiation, communication, and interpersonal skills, with the ability to build and maintain relationships with diverse stakeholders
• Self-motivated, goal-oriented, and able to work independently as well as collaboratively within cross-functional teams