Overview

We’re looking for a candidate to fill this position in an exciting company.

  • Medical input to the Global Development Team / Subteam
  • Medical Expert for clinical study team
  • Protocol development from concept to final protocol
  • Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
  • Scientific interpretation of data from clinical studies
  • May supervise other medical monitors on individual studies
  • Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs
  • Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
  • Presentation at academic congresses, investigator meetings and advisory meetings
  • Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
  • Providing medical/scientific input to evaluate potential business opportunities
  • MD or equivalent; Board Certification preferred
  • 5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)
  • Experience as a medical monitor for clinical trials required
  • Regulatory experience preferred
  • Publication in peer reviewed journals
  • Excellent written / oral communication skills
  • Attention to detail and ability to think strategically
  • Willingness to take on new responsibilities
  • Interest and ability to learn about new therapeutic areas
  • Interest in career progression and ability to take on a more senior roles in 1-3 years