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Director of Drug Safety

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Location
New York, NY
Job Type
Direct Hire
Degree
Doctor of Osteopathy, Medical Doctor
Date
Jul 11, 2018
Job ID
2559910
My client is in start-up mode seeks a Director to oversee clinical research and drug safety activities along with clinical research strategy. The ideal candidate will take on the following tasks:
  • Oversee clinical study activities.
  • Recruit, manage and develop a small clinical research and drug safety team.
  • Oversee data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, and assist with manuscript preparation.
  • Forecast clinical activities and assist in developing clinical operational budget.
  • Assist in oversight of clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment.
  • Provide safety surveillance for all clinical trial products for development of product safety profiles and informed consents, investigator brochures, protocols and clinical safety reports.
  • Coordinate safety surveillance procedures to ensure corporate compliance with national and international adverse event reporting requirements.
  • Assures compliance with applicable regulations and standard operating procedures for the reporting of adverse events to regulatory agencies.
  • Oversee the preparation of NDA Safety Updates, IND safety reports, investigator communications, Product Labeling/Package Inserts, Risk Management Plans and other reports as necessary.
 
Requirements:
  • MD/DO degree and Ophthalmology experience.
  • License to practice medicine -- US or equivalent
  • 5+ years of industry experience with knowledge of GCP, clinical trial conduct data interpretation and safety in clinical development.
  • Strong organizational and communication skills are required as well as in-depth knowledge of clinical research, including FDA and international regulations, GCPs, clinical study design and documentation, conduct of clinical trials and pharmacovigilance.
  • Program management skills enabling efficient planning and execution of program milestones within budget and in time.