[Hiring] VP, Clinical Science @AMER
Role Description
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.
This position will also lead and advise other parts of the organization through a formal consultation process, ensuring that the quality and reliability of studies are maintained and that clinical trials meet their objectives in collaboration with other members of the clinical research team including:
β’ Clinical Operations
β’ Pharmacovigilance (PV)
β’ Medical Affairs
β’ Regulatory
β’ Quality
β’ Manufacturing
β’ R&D
β’ Business Development
Key Accountabilities:
β’ Develop study documentation including, but not limited to study protocols, investigators brochures (IBs), informed consent documents, clinical dossiers for regulatory submissions.
β’ Provide scientific input into documentation including IBs, IMPDs, DSURs, and CSRs.
β’ Review study data including safety and efficacy data for accuracy and quality.
β’ Triage and delegate work requests to the in-house team of SMEs, while providing timeline, resource, and workload balancing.
β’ Work closely with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs.
β’ Assist in development and participate as needed, in Steering Committees and Advisory Boards with global thought leaders in appropriate indications.
β’ Provide senior management personnel regular updates on the progress of the clinical research.
β’ 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.
β’ Coordinate efforts associated with clinical imaging, pharmacology, biostatistics, and physics SMEs to address complex trial-related questions/strategy.
Qualifications
β’ Scientific background with university degree and MD required.
β’ 10+ years Clinical experience with strong sponsor or CRO experience required.
β’ 5+ yearsβ experience leading teams required.
β’ Detailed knowledge of global clinical trial regulations.
β’ Formal training in clinical diagnostic imaging (e.g. Radiology, Nuclear Medicine, Radiation Oncology) with Clinical Fellowship level training in Oncology associated field.
β’ Familiarity with managing groups within matrix teams.
Requirements
β’ Ability to plan, create, strategize and drive execution of multiple projects under tight timelines.
β’ Very good attention to detail and project completer.
β’ Ability to prioritize and manage time effectively.
β’ Strong organizational and interpersonal skills.
β’ Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel).
β’ Excellent oral and written communication skills.
β’ Ability to manage teams through complex problems and issues.
β’ Able to modulate and communicate with multiple stakeholders (e.g. Clinical Science, Managers, Physicists, Medical Affairs, Sales and Marketing etc.).
Benefits
β’ Financial: In line with Delegations of Authority Policy of the Board.
Key Capabilities
β’ Inclusive mindset: Demonstrate an understanding and appreciation for diversity and actively work to create an inclusive environment where everyone feels valued and respected.
β’ Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
β’ Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
β’ Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
β’ Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
β’ Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
β’ Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
β’ Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
β’ Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
β’ Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.
β’ Strong autonomy and ability to learn quickly and independently.
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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.
This position will also lead and advise other parts of the organization through a formal consultation process, ensuring that the quality and reliability of studies are maintained and that clinical trials meet their objectives in collaboration with other members of the clinical research team including:
β’ Clinical Operations
β’ Pharmacovigilance (PV)
β’ Medical Affairs
β’ Regulatory
β’ Quality
β’ Manufacturing
β’ R&D
β’ Business Development
Key Accountabilities:
β’ Develop study documentation including, but not limited to study protocols, investigators brochures (IBs), informed consent documents, clinical dossiers for regulatory submissions.
β’ Provide scientific input into documentation including IBs, IMPDs, DSURs, and CSRs.
β’ Review study data including safety and efficacy data for accuracy and quality.
β’ Triage and delegate work requests to the in-house team of SMEs, while providing timeline, resource, and workload balancing.
β’ Work closely with Clinical Operations, Medical Affairs, and asset matrix teams to ensure compliance with organizational SOPs.
β’ Assist in development and participate as needed, in Steering Committees and Advisory Boards with global thought leaders in appropriate indications.
β’ Provide senior management personnel regular updates on the progress of the clinical research.
β’ 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.
β’ Coordinate efforts associated with clinical imaging, pharmacology, biostatistics, and physics SMEs to address complex trial-related questions/strategy.
Qualifications
β’ Scientific background with university degree and MD required.
β’ 10+ years Clinical experience with strong sponsor or CRO experience required.
β’ 5+ yearsβ experience leading teams required.
β’ Detailed knowledge of global clinical trial regulations.
β’ Formal training in clinical diagnostic imaging (e.g. Radiology, Nuclear Medicine, Radiation Oncology) with Clinical Fellowship level training in Oncology associated field.
β’ Familiarity with managing groups within matrix teams.
Requirements
β’ Ability to plan, create, strategize and drive execution of multiple projects under tight timelines.
β’ Very good attention to detail and project completer.
β’ Ability to prioritize and manage time effectively.
β’ Strong organizational and interpersonal skills.
β’ Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel).
β’ Excellent oral and written communication skills.
β’ Ability to manage teams through complex problems and issues.
β’ Able to modulate and communicate with multiple stakeholders (e.g. Clinical Science, Managers, Physicists, Medical Affairs, Sales and Marketing etc.).
Benefits
β’ Financial: In line with Delegations of Authority Policy of the Board.
Key Capabilities
β’ Inclusive mindset: Demonstrate an understanding and appreciation for diversity and actively work to create an inclusive environment where everyone feels valued and respected.
β’ Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
β’ Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
β’ Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
β’ Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
β’ Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
β’ Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
β’ Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
β’ Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
β’ Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.
β’ Strong autonomy and ability to learn quickly and independently.
Apply tot his job
Apply To this Job