Remote Global Clinical Development Lead, Neuro-Oncology Diagnostic

Summary

Join Telix Pharmaceuticals as a Global Clinical Lead to lead clinical development of neuro-oncology imaging assets and drive clinical development strategy for innovative diagnostic programs in an area of high unmet need.

Requirements

• Bachelor’s degree plus 10+ years of clinical development within the pharmaceutical or biotechnology space or Advanced degree (e.g., MD, PhD, PharmD) in a relevant scientific discipline plus 5+ years of clinical development within the pharmaceutical or biotechnology space required
• Radiopharmaceuticals experience 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

Responsibilities

• Lead development of clinical development plans for diagnostic assets in neuro-oncology
• 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

Benefits

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