Associate
Medical Director
Location: Northeast
POSITION SUMMARY:
Key position within Clinical
Affairs is responsible for providing medical and scientific expertise to bring the high
quality and efficiency to the clinical trial development process for cardiovascular
devices in the pipeline. Under direction of VP, the mandate of the Associate Medical
Director is to maintain timelines by providing high level therapeutic support to internal
and external customers including project teams, functional units, investigators, and
regulatory agencies. The major responsibilities include early, hands-on operational
support to teams in clinical trial planning, protocol development, investigator selection,
training of internal and external personnel, medical monitoring for trial safety, and
quality control. He/she will be responsible for implementation of Corporate worldwide
practices, policies, and processes for the medical and clinical affairs function.
Duties and Responsibilities
of the Position:
Responsible for providing
cardiovascular area expertise to support development and execution of clinical trials in
device development process.
Review and editing of
protocols to insure accuracy, consistency with standard of care, logistical ease, and
internal consistency.
Provide medical monitoring
to insure patient safety and adequate reporting and coding of adverse events in clinical
trials.
Provide direct physician
support to quality assurance group for review of product complaints, reporting criteria,
health risk assessments, and product performance criteria.
Participate in writing and
editing of clinical reports for regulatory submission and updates to insure medical
accuracy.
Participate in development
of publication strategies, writing and editing of draft presentations and manuscripts, and
interface with principle investigators.
Oversight of core
laboratories to insure that requested services are appropriate for study purposes and
final deliverables are of adequate quality.
Ongoing development of
training programs to enhance therapeutic area knowledge in staff and provide protocol
specific updates.
Serve as physician
representative on internal committees.
Qualifications:
Medical degree with
subspecialty training in internal medicine, ideally cardiovascular disease.
Clinical Research experience
including multi-center, international trials.
Excellent communication
skills (oral and written).
Experience in writing
scientific reports.
Strong organizational and
interpersonal skills.
Willingness to travel (up to
40%)
Working regulatory knowledge
(FDA/CFR; EN540/GCP)
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