Senior Director / Vice-President Clinical Science (2 roles available!)

작업 내용

Telix is searching for two new Senior Directors or VPs of Clinical Science to oversee the scientific designing, implementing, and undertaking of clinical trials during the drug development process from Phase 0 to Phase 4 clinical trials, including both company sponsored and investigator led initiatives. The role is required to ensure that the quality and the reliability of the study are maintained and that clinical trials meet their objectives in collaboration with other members of the clinical research team including clinical operations, pharmacovigilance, medical affairs etc. The role is also to ensure that clinical trial regulations are met worldwide and within required timelines and budget, to the highest standards of Good Laboratory Practice (GLP), ICH guidelines, Good Clinical Practice (GCP) and according to regulatory guidelines, laws and Standard Operating Procedures (SOPs).

Key accountabilities will include:

• Developing studies from concept to synopsis to full protocol
• Developing study documentation including, but not limited to informed consent documents and regulatory submissions and, providing scientific input into documentation such as investigator brochures, IMPDs, DSURs and CSRs
• Reviewing study data including safety data for accuracy and quality and providing medical monitoring for ongoing clinical trials
• Engaging with investigators and visit sites
• Developing and conducting steering committees and advisory boards with global thought leaders in appropriate indications
• Providing updates to senior management on the progress of the clinical research

To be considered for the role, candidates must have a scientific background with university degree and either a PhD or MD (or equivalent). Progressive clinical experience in biotech or a CRO must be demonstrated along with detailed knowledge of global clinical trial regulations. Applicants with relevant therapeutic area expertise in GU oncology, rare disease or Glioblastoma will be highly regarded.

This is an exciting time for Telix. Come join us on our mission to help patients with cancer live longer, better quality lives!

No agency submissions will be considered.