Medical Director
Apply NowCompany: Catalyst Clinical Research
Location: Raleigh, NC 27601
Description:
Experience Required
Our client, located in the Raleigh, NC area is seeking a Consultant Medical Director. This position could potentially become permanent for the right candidate. The Medical Director assumes overall responsibility for the company's activities within drug development and safety. Develops and administers medical policies, practices and programs to promote organizational excellence. Provides guidance to management and staff in application of medical affairs matters. Principal Duties and Responsibilities: Plans and directs all aspects of companies medical policies and programs. Ensures all clinical programs are in compliance and are executed expeditiously. Oversees pharmacovigilance/risk management processes for investigational products. Oversees project management and clinical operations staff for clinical development programs. Provides medical expertise for business development/licensing staff. Responsible for all safety and medical monitoring of trials, and submission of expedited safety reports, analysis of similar events to the FDA in conjunction with Regulatory Affairs. Reviews scientific publications and scientific meeting presentations produced by parent company, staff and affiliate offices, and collaborative entities including physicians and co-marketing partners. Responsible for strategic clinical relationships with Advisory Board Members, Data Safety Monitoring Boards, and other relevant physicians and scientific consultants. Writes research publications appropriate to support clinical and business activities. Ensures that company-sponsored clinical studies, or studies assigned by company affiliates, are conducted in compliance with protocol, GCP and FDA regulations, and company policies and procedures. Serves as a medical information resource for staff. Develops and presents scientific material on investigational drugs to internal and external audiences. Performs a variety of other tasks. Leads and directs the work of others. Knowledge and Skills: Bachelor's degree and an advanced degree in medicine required with at least 8 years of relevant medical and pharmaceutical experience. Participation in the submission of at least 2 INDs. Familiar with a variety of the field's concepts, practices, and procedures. general public. The ability to present facts and recommendations effectively in oral and written form. Relies on experience and judgment to plan and accomplish goals. Requirements include a thorough understanding of GCPs, FDA and ICH guidelines, excellent written and oral communication skills, a detail-oriented work style and the ability to handle multiple tasks. Relies on extensive experience and judgment to plan and accomplish goals.
Our client, located in the Raleigh, NC area is seeking a Consultant Medical Director. This position could potentially become permanent for the right candidate. The Medical Director assumes overall responsibility for the company's activities within drug development and safety. Develops and administers medical policies, practices and programs to promote organizational excellence. Provides guidance to management and staff in application of medical affairs matters. Principal Duties and Responsibilities: Plans and directs all aspects of companies medical policies and programs. Ensures all clinical programs are in compliance and are executed expeditiously. Oversees pharmacovigilance/risk management processes for investigational products. Oversees project management and clinical operations staff for clinical development programs. Provides medical expertise for business development/licensing staff. Responsible for all safety and medical monitoring of trials, and submission of expedited safety reports, analysis of similar events to the FDA in conjunction with Regulatory Affairs. Reviews scientific publications and scientific meeting presentations produced by parent company, staff and affiliate offices, and collaborative entities including physicians and co-marketing partners. Responsible for strategic clinical relationships with Advisory Board Members, Data Safety Monitoring Boards, and other relevant physicians and scientific consultants. Writes research publications appropriate to support clinical and business activities. Ensures that company-sponsored clinical studies, or studies assigned by company affiliates, are conducted in compliance with protocol, GCP and FDA regulations, and company policies and procedures. Serves as a medical information resource for staff. Develops and presents scientific material on investigational drugs to internal and external audiences. Performs a variety of other tasks. Leads and directs the work of others. Knowledge and Skills: Bachelor's degree and an advanced degree in medicine required with at least 8 years of relevant medical and pharmaceutical experience. Participation in the submission of at least 2 INDs. Familiar with a variety of the field's concepts, practices, and procedures. general public. The ability to present facts and recommendations effectively in oral and written form. Relies on experience and judgment to plan and accomplish goals. Requirements include a thorough understanding of GCPs, FDA and ICH guidelines, excellent written and oral communication skills, a detail-oriented work style and the ability to handle multiple tasks. Relies on extensive experience and judgment to plan and accomplish goals.