Merck & Co. is looking to solve the problem of managing studies to provide safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products in the Neuroscience Medicines area.
Requirements
- Alzheimer's Disease
- Clinical Development
- Clinical Judgment
- Clinical Medicine
- Clinical Research
- Clinical Research Management
- Clinical Studies
- Clinical Testing
- Clinical Trials
- Data Analysis
- Decision Making
- Drug Development
- Ethical Standards
- Intellectual Curiosity
- Interdisciplinary Problem Solving
- Neuropathic Pain
- Neuroscience
- Neuroscience Research
- Pain Management
- Pharmaceutical Development
- Regulatory Affairs Compliance
- Regulatory Compliance
- Scientific Leadership
- Scientific Publications
Responsibilities
- 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.
Other
- M.D or M.D./Ph.D.
- Must have experience in industry or senior faculty in academia
- Minimum of 3 years of clinical medicine experience
- Minimum of 3 -5 years of industry experience in drug development or biomedical research experience in academia
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
