Basic qualifications:
• Bachelor’s Degree or equivalent in science or health-related field.
• Experience leading Phase 1 to 4 clinical development project teams; can lead studies from early stage through to regulatory submission and market support.
• Advanced understanding of clinical development and/or marketed support such that the employee is able to recommend, influence, and implement improvements to these processes. Understands the study, project, and program level and can function successfully across a variety of projects.
• Demonstrates a thorough knowledge of worldwide regulatory and safety requirements as pertains to drug development, research projects, and/or market support.
• Understands the impact of decisions and maintains awareness of business drivers and alternative solutions for project delivery.
• Demonstrates the ability to develop self and others by providing coaching and constructive feedback to reports, peers, and managers
The successful candidate will be able to demonstrate the following:
• Scientific Credibility: Demonstrated by the ability to understand the scientific principles of the study design, the compound class, relevant therapeutic area and how an individual study contributes to the development of a drug. In particular they will have experience of techniques and practices that are used to deliver the study outputs.
• Judgment: Evidence of sound scientific and ethical judgment. The outputs from each study must be supportable under the scrutiny of regulators or the wider scientific community. Each study must be conducted in the correct ethical and scientific manner, adequately documented and any deviations or discrepancies dealt with contemporaneously. The job holder understands the key customers for each study and knows when to appropriately request medical oversight of clinical issues.
• Leadership: Demonstrated ability to lead the resolution of issues related to individual or groups of studies. Capable of leading a matrix team in the delivery of study objectives including guidance of less experienced staff in the delivery of their roles. Capable of coordinating the delivery of multiple studies, at times simultaneously, within a development plan.
• Teamwork: Established reputation for working within a team and developing cohesiveness for all team members. The individual is able to overcome technical, business and cultural differences to meet objectives. Actively promotes and utilizes the skills and contributions of others within the project and line.
• Corporate Agility: Adaptable to the dynamic environment within their role, demonstrating an ability to alter direction at short notice to deliver business advantage to the organization.
• Decision Making: Makes decisions which balance risk/benefit with clear understanding of impact on project and takes action to mitigate risk where appropriate.
• Communication : Applies effective verbal, written and presentation skills. Good organizational skills.
Preferred qualifications:
• Advanced Degree
• Experience in dermatology development
Details:
Clinical Scientist to support clinical development programs
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