- Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area
- The Senior Director will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication
- Specifically, the Senior Director May Be Responsible For:
- 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 Atherosclerosis drugs
- Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
- Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Atherosclerosis 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
- Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds
- Support of business development assessments of external opportunities
- Supervise the execution of clinical studies
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility
- The Senior 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 responsibility
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
- Facilitate collaborations with external researchers around the world
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely
