Senior Director of Clinical Affairs

  • location: Monmouth Junction, NJ
  • type: Permanent
  • salary: $230,000 - $240,000 per year
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job description

Senior Director of Clinical Affairs

job summary:
** Immediate need for a strategic, hands-on, and problem-solving Senior Director of Clinical Affairs. This individual must have prior industry knowledge in cardiovascular disease or acute critical care needs.**

 
location: Monmouth Junction, New Jersey
job type: Permanent
salary: $230,000 - 240,000 per year
work hours: 9 to 5
education: Doctorate
 
responsibilities:
  • Development of trial protocol and other related study documents.
  • Oversight of all interactions with external stakeholders including regulatory agencies (e.g. FDA), advisory boards and study committees (Executive committee, DSMB, CEC, etc.).
  • Oversight of safety reviews and adverse event reporting, including drafting responses to regulatory questions and ethics committees as necessary.
  • In conjunction with Clinical Operations monitoring of clinical trial quality and conduct
 
qualifications:
  • An M.D. degree and at least 5 years of experience in drug or device development.
  • Therapeutic area expertise in cardiovascular disease and/or acute critical care is highly desired.
  • Track record of successfully supporting, developing and executing clinical development plans.
 
skills: FDA, Clinical research, Clinical Study Design, Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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