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Telix Pharmaceuticals - Fishers, IN
posted 5 days ago
About the position
We are seeking an experienced Oncology Clinical Imaging expert to join the Nuclear Medicine Center of Excellence (NMCOE) for Telix Pharmaceuticals, under the Division of Precision Medicine. The successful candidate will be responsible for design and execution of imaging protocols using standard and advanced radiological techniques. Optimizing, analyzing and interpreting data from these studies to advance the development of novel diagnostic and therapeutic radiopharmaceuticals in the setting of cross functional teams will be required. The Clinical Imaging Director will work closely with the respective Global Clinical Leads, Global Program Leads, Clinical Operations, Biostatistics and other relevant areas within the organization to advance Telix Group's assets towards optimized clinical adoption. This will be undertaken via a deep knowledge of advances in imaging in oncology. Core team members of the NMCOE will include the successful candidate, a Nuclear Medicine Physician and Radiation Physicist.
Responsibilities
- Develop/execute protocols and workflows on imaging studies to enable the advancement of diagnostic and therapeutic radiopharmaceuticals
- Lead development of imaging sections of clinical study documentation and regulatory documents
- Lead the design, analysis, review, and quality control of imaging data to ensure accuracy and quality
- Oversight of third-party vendors, such as imaging CROs
- Collaborate with Global Clinical Leads, Global Program Leads, Biostatistics, Clinical Operations, and other cross-functional colleagues to ensure strategic and effective implementation of novel imaging approaches in clinical studies
- Prepare and deliver presentations, proposals, and reports for senior management, partners, and other stakeholders
- Scientific input and oversight on studies with endpoints utilizing NM/SPECT/PET techniques
- Engage with investigators and visit sites
- Maintain compliance with regulations, ICH/GCP Guidelines
- Image analysis/review sessions with study teams, sites and KOLs
- Input into AI/ML imaging initiatives
- Provide input to Business Development, M&A activity and Medical Affairs
Requirements
- Bachelor's degree in biomedical science or imaging-related field is required
- 10+ years of experience in nuclear medicine with a focus to oncology
- Experience in clinical development within the pharmaceutical or biotechnology industry
- Strong knowledge of clinical trial design, methodology, and regulatory requirements
- Track record of working effectively with imaging CROs and vendor management
- Experience in authoring clinical study and regulatory documents
- Familiarity with GxP and regulatory guidelines for clinical trials
- Experience in the use of image analysis software in radiology and nuclear medicine
