The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology at Merck & Co., Inc.
Requirements
- Allergy and Immunology
- Clinical Development
- Clinical Immunology
- Clinical Investigations
- Clinical Medicine
- Clinical Research
- Clinical Trial Planning
- Clinical Trials
- Clinical Trial Support
- Cross-Functional Teamwork
- Immunogenicity Assays
- New Technology Integration
Responsibilities
- Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.
- Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline
- Developing clinical development strategies for investigational drugs and 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 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
- Supervise the activities of Clinical Scientists in the execution of clinical studies.
Other
- M.D., D.O., M.D./PhD, or D.O./PhD
- Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).
- Demonstrated record of scientific scholarship and achievement
- Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred
- Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.