Director, Clinical Development Sciences Neurology (NMO)

Alexion

Job Description

Position Summary

Seeking an individual who is Board Certified in Internal Medicine with 3-5 years of industry experience. This individual will serve as a medical expert for the study team and medical monitor for phase 2-4 clinical trials. This position additionally offers substantial opportunities for regulatory and commercial interactions and career advancement in the fast-moving area of rare disease.
 

Job Duties & Responsibilities

  • Medical Expert for clinical study team
  • Protocol development from concept to final protocol
  • Strategic guidance to phase II/III development programs and oversight of global clinical trials/trial team (s) on assigned program(s)
  • 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
  • DMC development and  liaison
  • Medical oversight of commercial documents

Essential Qualifications

  • MD or equivalent
  • Board Certified in Internal Medicine or Neurology
  • Minimum 3-5 years of industry experience 
  • Previous history running clinical trials
    • Safety medical monitoring  and reporting experience
    • Protocol development experience
    • Regulatory experience
    • Basic statistical knowledge
  • Excellent written / oral communication skills
  • Ability to think strategically
  • Willingness to take on new responsibilities
  • Interest in career progression and ability to take on a more senior roles in 1-3 years

Preferred Qualifications

  • Subspecialty certification
  • History of academic clinical or basic science research
  • Business development experience
  • Publication in peer reviewed journals

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