VP, Clinical Science

Telix Pharmaceuticals (AMER)

3h•Hybrid

About The Position

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.

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
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 skills
Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
Excellent oral and written communication skills
Ability to manage teams through complex problems and issues
Able to modulate and communicate with multiple stakeholders (e.g. Clinical Science, Managers, Physicists, Medical Affairs, Sales and Marketing etc.)

Responsibilities

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