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Telix Pharmaceuticals - Fishers, IN
posted 5 days ago
About the position
We are seeking a dynamic and experienced Global Clinical Development Lead in Renal Cancer as part of our Clinical Strategy and Innovation team. The successful candidate will be responsible for designing and executing clinical trials for novel radiopharmaceutical therapeutics in renal cancer. This position offers a unique opportunity to drive clinical development strategy in an area of high unmet need. The Global Clinical Lead will ensure the renal cancer therapeutic 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 towards the clinic. This will be undertaken via a deep working knowledge of the existing and future competitive landscape in uro-oncology.
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 Company's objectives, and the needs of regulatory authorities, healthcare professionals, patient groups, guidelines committees and payors
- Develop clinical study documentation including informed consent documents, imaging charters, study manuals and final regulatory dossiers in collaboration with relevant cross-functional teams and medical writers
- Lead clinical scientific input into documentation including investigator brochures, IMPDs, safety reports, 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 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
Requirements
- Medical degree or PhD required
- Clinical experience in medical oncology required; Nuclear medicine or renal cancer experience is highly preferred
- 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
- Experience with regulatory submissions (e.g., IND, CTA) and interaction with regulatory agencies (e.g., FDA, EMA) is preferred
