Global Clinical Lead, Renal Cancer Therapeutics

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Telix Pharmaceuticals Limited

๐Ÿ“Remote - United States

Job highlights

Summary

Join Telix Pharmaceuticals, a global radiopharmaceutical company, as their Global Clinical Development Lead in Renal Cancer. You will be responsible for designing and executing clinical trials for novel radiopharmaceutical therapeutics, ensuring programs are founded on sound scientific decision-making and progress efficiently towards commercialization. This role requires collaboration with various cross-functional teams and external stakeholders. The ideal candidate will have a medical degree or PhD, extensive clinical development experience, and a strong understanding of clinical trial design and regulatory requirements. Telix offers a supportive work environment, competitive salaries, bonuses, equity incentives, generous vacation time, wellness days, and support for learning and development.

Requirements

  • Medical degree or PhD required
  • Clinical experience in medical oncology required
  • 5+ years of experience in clinical development required
  • Strong knowledge of clinical trial design, methodology, and regulatory requirements
  • Successful leadership and project management of clinical development programs

Responsibilities

  • Lead development of clinical development plans for therapeutic assets in renal 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 Companyโ€™s objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
  • Develop โ€“ in collaboration with relevant cross-functional teams and medical writers โ€“ 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

Preferred Qualifications

  • Nuclear medicine or renal cancer experience is highly preferred
  • Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred
  • Strong understanding of uro-oncology

Benefits

  • Competitive salaries
  • Annual performance-based bonuses
  • An equity-based incentive program
  • Generous vacation
  • Paid wellness days
  • Support for learning and development
  • Hybrid and remote employees located all around the world

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