Senior Principal Scientist, Clinical Research, Neuroscience

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products.

Requirements

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications;
• Developing clinical development strategies for investigational or marketed Neuroscience drugs that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations;
• 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 Neuroscience 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.
• Provide support for other therapeutic areas regarding clinical issues related to Neuroscience.
• Supervise the activities of Clinical Scientists in 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;

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