Associate Director, Clinical R&D Urology FIPCUS |
| Location: | Parsippany, NJ |
| Exempt/Non-Exempt: | Exempt |
| Benefits: | Medical Coverage, Dental Coverage, Prescription Drug Coverage, Fertility Drug Benefit, Life Insurance, Accidental Death & Dismemberment, Insurance, Short Term Disability Insurance, Long-term Disability Insurance, Health Care Flexible Spending, Account, Dependent Care Flexible Spending Account, Employee Assistance Program, 401(K) Program, Vacation Program, Personal days, Holidays, |
| Employment Type: | Full Time |
| Department: | FIPCUS (Clinical R&D) |
| Description: | SUMMARY: The Associate Director, Clinical Research and Development will be primarily responsible for preparation of clinical protocols, clinical trials initiation, NDA preparation, IND preparation, management and medical monitoring in the Urology therapeutic area. This position supports all activities related to the clinical product development programs. The Associate Director reports to the Director of Clinical R & D, Urology.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Study planning and design; clinical protocol preparation and implementation
Initiate, coordinate enrollment and monitor clinical studies Phase I-IIIb
Manage the clinical data analysis and interpretation of clinical results
Reporting and filing of data from clinical development studies Phase I-IIIb
Periodic and annual drug safety reporting
Prepare presentations on clinical development plans, project progress updates, clinical data
Support Medical Affairs and Commercial as appropriate
Prepare for and participate in Advisory Board Meetings and Investigators Meetings
Participate in multidisciplinary projects designed to support new drug development or commercialization of existing Ferring products
Prepare NDAs and INDs
QUALIFICATION REQUIREMENTS:
M.D. with 3-5 years of pharmaceutical industry or related experience, including clinical project management in the area of Urology or Internal Medicine.
Clinical and scientific expertise in preparing clinical and regulatory documents and/or publications, demonstrating ability to organize, analyze and interpret clinical and scientific data
Commitment to team work and to provide leadership by example
The above is intended to describe the essential job functions and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
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