Science, Pharmaceutical & Food

Medical Director – Patient Safety

  • Full Time
  • United States
  • 41999344

Overview:

  • Work for small biotech
  • Manage safety aspects of early phase trials
  • Hybrid Role based in the U.S

 

Benefits:

  • Work on a passionate multidisciplinary team
  • Opportunity to take ownership of entire safety program from inception
  • Competitive salary package

About the company:

Out client is in the early stages of development and is developing a highly novel asset in an emerging area within Lifesciences. Their cutting edge technology is looking to close the gap on previous treatment options. 

Responsibilities:

  • Design, manage and implement the signal detection strategy for the client’s portfolio
  • Coordinate with cross functional internal teams over safety information
  • Design and assist with key clinical trial documentation, protocols and study specific brochures
  • Preparation and review of relevant periodic reports – IND Annual Reports, DSUR, PBRER etc
  • Contribute strategically for Health Authority interactions
  • Prepare safety sections for regulatory filings – IND, NDA, MAA etc
  • Have a heavy involvement with abstracts, posters, papers and other scientific literature
  • Manage safety evaluation activities for new business proposals

Qualifications:

  • Medical Doctor (M.D.) degree required
  • 3 – 5 years’ experience in drug safety 
  • Ideally has set up ability to set up signal detection and PVS programs from inception
  • Ability to work cross functionally in a dynamic, multidisciplinary environment
  • Excellent communication skills and ability to lead teams

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