Executive Director/Vice President, Medical and Safety Monitoring
NOTE: This role may be based remotely at any location within the U.S.
The Executive Director/Vice President, Medical and Safety Monitoring, is responsible for strategic and tactical medical and safety monitoring services, including medical writing. The Executive Director/Vice President, Medical and Safety Monitoring effectively manages the medical and safety team, and the review/creation of processes/standard operating procedures, and project oversight for assigned clinical studies/services. Medical Monitors and safety staff will report to this individual. He/She will oversee daily operations, resourcing, hiring, performance reviews, financials, budgeting, systems and support proposal and business development for new opportunities.
- Managerial Responsibilities
- Train, mentor, monitor, and supervise the medical and safety monitoring personnel
- Coordinate teams and assignments of resources across projects and ensure all projects stay on target
- Ensure overall quality and deliverables
- Conduct performance evaluations for direct reports, including guidance toward reaching organizational and career goals
- Inform the executive leadership of project status and employee issues
- Oversee monthly revenue reporting related to statistical project deliverables
- Prepare monthly billing reports for biostatistics and SAS programming activities
- Responsible for P&L management of the Medical/Safety Monitoring department inclusive of the development of the annual budget
- Understand the Advanced Clinical (AC) overall financial plan and our contribution to and support of AC's overall financial goals
- Maximize productivity of direct reports to exceed AC budget goals
- Write training and establish training programs for new processes
- Work as a member of an integrated Medical/Safety Monitoring team to develop strategies, identify possible improvements to current processes, systems, develop new processes as needed, identify new systems to improve quality, differentiators and efficiency of services
- Identify and implement improvements to current processes/systems, determine new processes that are need, and initiate a plan to improve or develop processes
- Other global management responsibilities as requested by executive leadership
- Create, revise and review Standard Operating Procedures (SOPs) to recognize and prevent potential regulatory issues
- Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
- Oversees the management of medical/safety monitoring during the course of clinical trials and projects
- Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
- Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
- May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
- Ensures delivery of medical/clinical direction to investigative sites per contract deliverables
- Oversees preparation of medical and safety plans for clinical trials/services
- Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts
- Oversees reviews and directs medical and safety sections of regulatory document submissions
- May participate in Investigator meetings
- Develops and assists other staff in the development of processes, timelines, planning, and strategy
- Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review
Education: Bachelor's degree in healthcare, analytical, biological or pharmacy science. Advanced degree, MD or DO or PharmD preferred. Commensurate experience will be considered.
Certification: If MD or DO or PharmD, preferably board certified in the US
Experience: Minimum of ten (10) years of clinical research and medical/safety management experience in the pharmaceutical industry
This role requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to, apply ICH GCP and applicable FDA and international pharmacovigilance regulations and guidelines. Possesses exceptional leadership skills and proven industry vision. Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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As a medical writer, Shaniya is responsible for compiling the data from clinical study reports, analyzing what’s been learned from conducting the trial, and summarizing that information into a scientific document.
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