VP, Clinical Science

See Yourself at Telix

The Vice President, Clinical Science is a senior leadership role that exists within Telix to support the design, strategy, and operationalization of clinical trials during the drug development process from Phase 0 to Phase 4 clinical trials through the leadership over a team of subject matter experts (SMEs) consisting of clinical medical physics, clinical pharmacology, imaging sciences and biostatistics. Functioning as an expert facilitator to asset matrix teams, clinical science leads, and other internal stakeholders, this position will also lead and advise other parts of the organization through a formal consultation process. The position is required to ensure that the quality and the reliability of studies are maintained and that clinical trials meet their objectives in collaboration with other members of the clinical research team including Clinical Operations, Pharmacovigilance (PV), Medical Affairs, Regulatory, Quality, Manufacturing, R&D, and Business Development.

Key Accountabilities

• Develop study documentation including, but not limited to study protocols, investigators brochures (IBs), informed consent documents, clinical dossiers for regulatory submissions
• Provide scientific input into documentation including IBs, IMPDs, DSURs and CSRs
• Review study data including safety and efficacy data for accuracy and quality
• Triage and delegate work requests to the in-house team of SMEs, while providing timeline, resource and workload balancing
• 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 in appropriate indications
• 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 SMEs to address complex trial related questions/strategy

Education and Experience

• 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

Personal Attributes

• Ability to plan, create, strategize and drive execution of multiple projects under tight timelines
• Very good attention to detail and project completer
• Ability to prioritize and manage time effectively
• Strong organizational and interpersonal