Senior Global Clinical Lead, Prostate Cancer Imaging

Summary

Join Telix Pharmaceuticals as a Sr. Global Clinical Lead in Prostate Cancer Imaging and contribute to the international rollout of its prostate cancer imaging agent. You will design and execute clinical trials for novel radiopharmaceutical products, ensuring alignment with regulatory requirements and stakeholder needs. This role involves leading clinical development plans, collaborating with cross-functional teams, and generating clinical data for commercialization. The position requires a PhD or Medical degree, extensive clinical development experience, and strong leadership skills. You will work in a matrix organization, collaborating with global program leads, regulatory affairs, and medical affairs teams. Telix offers competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Requirements

• PhD or Medical degree required
• Clinical experience in medical oncology or nuclear medicine is essential
• 7+ years of experience in clinical development required
• 5+ years leading high functioning global matrix teams required
• Strong knowledge of clinical trial design, methodology, and regulatory requirements required
• Successful leadership and project management of clinical development programs required

Responsibilities

• Lead development of clinical development plans for imaging assets in prostate cancer
• 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
• Leadership and oversight of a the precision medicine clinical development team

Preferred Qualifications

Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development