FierceBiotech and FiercePharma Jobs
Medical Director - Boyle & Associates
Categories: Pharmaceutical
Position Description
Company is a leading international provider of pharmaceutical and biotechnology product development services. Our employees work in state-of-the-art facilities using leading edge technologies to meet exciting drug development challenges. We are seeking candidates for the following position located in RTP, North Carolina:
Medical Director
Responsible for all medical aspects of Phase I and BA/BE study conduct, either by direct performance of medical acts or by oversight of other medical personnel.
Key Responsibilities:
Ensure the protection of the rights, safety, and welfare of all human subjects participating in studies.
Review all protocols and approve or disapprove same from the point of view of safety and feasibility.
Serve as Principal Investigator on all studies unless another individual is designated as Principal Investigator for a specific study.
Meet with monitors from sponsoring companies for study initiations and follow up visits.
Perform screening medical exams, including physical exams and interpreting medical tests and ECGs, on all subjects who are screened for studies.
Oversee the conduct of all medical procedures performed in studies, to insure that they are done correctly and that the health and safety of all subjects is maintained.
Monitor all subjects during studies to insure that their health and safety is maintained.
Determine the cause of any adverse event and its relationship to study drug. Report promptly to the IRB and sponsor any serious or unexpected adverse events.
Communicate with other physicians who may be involved as principal investigator or sub-investigator in a study and /or whose patients may be involved in studies.
Delegate ACLS certified RN’s to evaluate and defibrillate subjects/patients when a physician is not present under standing orders for appropriate conditions.
Qualifications include M.D. or D.O. degree with current license to practice in the State of North Carolina; at lease five years of clinical practice experience, including residency; excellent communication skills as well as team-building and teamwork skills. Previous experience in conducting pharmaceutical research is desirable, but not required.
We offer competitive salary, a comprehensive benefits package and advancement opportunity.


