The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Late Stage Oncology - Late Stage therapeutic area. The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Requirements
- Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications
- Developing clinical development strategies for investigational or marketed RCC drugs
- Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
- Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs
- Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication
- Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
- Supporting business development assessments of external opportunities
- Actively engaging with other functional areas in support of study execution
- Working closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
- Assisting the Executive Director and/or Associate Vice President in ensuring that appropriate personnel are informed of the progress of studies of our company and competitors' drugs
- Providing expert opinion, internally and externally, on relevant scientific questions within their responsibility
- Maintaining a strong scientific fund of knowledge by maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies, identifying scientifically and operationally strong investigators, establishing communications with prominent clinical investigators, and attending appropriate scientific meetings
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
