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
- 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
- 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.