Telix Pharmaceuticals Limited

Developing theranostics (nuclear medicine) for prostate, kidney, glioblastoma, haematologic cancers and rare diseases.

VP, Clinical Science

Vice PresidentVice PresidentFull TimeRemoteTeam 501-1,000Since 2015H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

20 days ago

Salary

Not specified

Postgraduate Degree10 yrs expEnglish

Job Description

• Support the design, strategy, and operationalization of clinical trials during the drug development process from Phase 0 to Phase 4 • Develop study documentation including study protocols, investigators brochures, informed consent documents, clinical dossiers for regulatory submissions • Provide scientific input into documentation including investigators brochures, investigational medicinal product dossiers, developmental safety update reports and clinical study reports • Review study data including safety and efficacy data for accuracy and quality • Triage and delegate work requests to the in-house team of subject matter experts • Work closely with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs • Assist in development and participate as needed, in Steering Committees and Advisory Boards with global thought leaders • Provide senior management personnel regular updates on the progress of the clinical research • Review imaging studies and be qualified to provide input on interpretation, quality assurance, accuracy of imaging interpretation, and final review of imaging, protocols, and imaging charters prior to implementation • Coordinate efforts associated with clinical imaging, pharmacology, biostatistics, and physics subject matter experts to address complex trial related questions/strategy

Job Requirements

  • Scientific background with university degree and MD required
  • 10+ years Clinical experience with strong sponsor or CRO experience required
  • 5+ years’ experience leading teams required
  • Detailed knowledge of global clinical trial regulations
  • Formal training in clinical diagnostic imaging (e.g. Radiology, Nuclear Medicine, Radiation Oncology) with Clinical Fellowship level training in Oncology associated field
  • Familiarity with managing groups within matrix teams

Benefits

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

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