Clinical Director, Oncology Early Development
Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Early Oncology therapeutic area. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical Director may manage the entire cycle of clinical development for their signed studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Role Responsibilities: Specifically, the Clinical Director may be responsible for: 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 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 The Clinical Director may: Actively engage with other functional areas in support of study execution Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs Provide expert opinion, internally and externally, on relevant scientific questions within their responsibilityThe Clinical Director is responsible for 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 who can assist in the development of our company's investigational and marketed drugs Establishing communications with prominent clinical investigators in his/her particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibilityTo accomplish these goals, the Clinical Director may: Author detailed develo...