Director, Clinical Research - Neuroscience 9/17/2016
Woodcliff Lake, NJ
JOB DESCRIPTIONAPPLY Department Name
Clinical Research GM
Woodcliff Lake, NJ
Due to expansion of program needs, the Neurology Business Group within Eisai Inc. is looking for a dedicated leader to provide medical expertise as Director of Clinical Research for a Sleep Disorders Program in Phase II and Phase III. The incumbent will serve as both the Medical Monitor for the overall Program and potentially as a Study Director. The Program involves collaboration with a co-development partner.
The Director, Clinical Research will make preparations for registration dossiers and Advisory Committee Meetings and, communicate with Health Authorities in support of a global submission.
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 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.
- MD required with Board Certification in Psychiatry, Neurology or Sleep Medicine preferred.
- 3 - 5 years of clinical research in Neuroscience within a pharmaceutical environment
- Study-specific experience in the areas of Sleep Disorders and/or Alzheimer's Disease is desirable but not required
- In-depth knowledge of drug development principles and clinical trial execution
- Experience conducting clinical trials and basic knowledge of regulatory requirements is required
- Prior experience communicating with and presenting to Regulatory Authorities on study/program design strategy and analysis of results as they relate to filings and clinical trials is preferred
- Prior partnership experience in drug development is highly desirable
- The ability to manage the complexities associated with co-development efforts and work cross functionally with a collaborative style that builds alliances and emphasizes Eisai Core Values (integrity, respect, professionalism, quality and teamwork) in a fast paced environment
- Strong team leadership and problem solving skills
- The ideal candidate is persuasive, effective and flexible in personal interactions at all levels. with strong oral and written communication skills
- Occasional travel to Investigator Meetings; up to 20% travel
Auto req ID
Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet