|The Director, Clinical Research requires a dynamic individual with an MD and mid-level experience in the pharmaceutical industry or comparable background in academia. The position is intended to provide the organization with a qualified individual to design and to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by potentially performing medical monitoring for these and, possibly, other studies. |
Responsibilities include but are not limited to:
- Directing and implementing clinical research plans (CDP) and programs according to established design principles
- Directing the integration of the CDP and drug development plans - Leading the development of clinical protocols to meet CDP objectives
- Serving as a Study Director and driving the execution of the study from protocol concept to final report, including interpretation of clinical data
- Serving as the Medical Monitor, depending on qualifications, for the overall clinical program to review and monitor study safety data.
- Implementing strategies to identify, monitor and resolve clinical program/trial issues
- Serving as subject matter expert to provide direction to all project team functions, organizing Advisory Board Meetings (e.g.) agenda setting, and identifying and liaising with key opinion leaders regarding program strategy and scientific advice
- interpreting study data and developing the integrated summaries of safety and efficacy
- Contributing clinical expertise and content to regulatory documents (e.g., briefing books, NDAs, etc.)
- May represent Clinical in discussions with Health Authorities.
Job Qualifications • MD or Ph.D required
• 3-5 years of experience depending upon credentials, in pharmaceutical clinical research or clinical scienctific background, preferably with experience in neuroscience and especially dementia (e.g., Alzheimer’s disease)
• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation
• Working knowledge of currently available clinical technologies and assessment tools, and drug mechanisms of action
• Knowledge of GCP and local regulatory requirements