Medical Director / Senior Director

  •  

Parsippany, NJ

5 - 7 years

Posted 185 days ago

JOB DESCRIPTION

The Medical Director / Senior Director will be responsible for:

  • Overseeing all medical aspects of study design; medical monitoring of clinical studies; and, medical evaluation of pharmacovigilance and drug safety reports (pre- and post-marketing)
  • Assisting with the execution of clinical studies to establish the safety, efficacy and commercial viability of new products
  • Actively participating in site selection and assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures
  • Assisting with study vendors selection and education
  • Working with Clinical and Regulatory Affairs in the preparation of project- related documents and regulatory submissions, including Investigator's Brochures, Annual Reports, INDs and NDA's
  • Participating in the formulation of overall clinical strategy
  • Handling other duties, as needed

REQUIRED SKILLS

  • 5+ years of Clinical Research experience in the Biotechnology and/or Pharmaceutical industry
  • MD and/or DO from an accredited College or University
  • Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development regulations and processes
  • Solid problem solving and time management skills
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
  • Able to multitask efficiently and effectively 

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