Responsible for directing the clinical development and medical affairs functions for the gastroenterology diagnostics and therapeutic product lines for the company.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties as assigned.
Act as Medical Monitor for safety evaluation as appropriate for all GI products
Identify, develop and maintain relationships with key opinion leaders, lead clinical investigators and advocates to increase awareness about Prometheus through the development of medical and scientific presentations and information
Serve as an internal thought leader and leading spokesperson relative to medical information and inquiries regarding Prometheus diagnostic and therapeutic products
Provide clinical, medical and technical information to support Prometheus' ongoing clinical programs and post market data and provide a focal point for product safety information and awareness
Serve as the clinical leader on Product Review Committees by providing insight to support advancement of programs
Serve as a clinical representative on current and future project teams in diagnostic and drug development programs
Respond to and supply necessary medical and clinical data for commercial, clinical development and regulatory affairs as well as any external customers or clients
Provide internal review and external leadership for ongoing clinical trials
Identify, develop and maintain collaborative relationships within the medical community to communicate scientific and medical information and further increase the awareness about Prometheus and its diagnostic and therapeutic products
Make medical and scientific presentations, utilizing technical information and research protocols on behalf of Prometheus' areas of interest with health care leaders, key opinion leaders, lead clinical investigators, academic institutions, managed care leaders and advocates
Work closely with the clinical and commercial teams to maintain a clear understanding of Prometheus marketed products and services as well as those in development in order to provide regular information to marketing on field based issues and trends
Educate and facilitate key opinion leader development regarding ongoing and future clinical trials
Support thought leaders in developing concepts and letters of intent for investigator supported clinical, medical and outcomes trials
Moderate peer discussions and reviews through regional and national advisory panels and medical education programs
Develop and maintain any scientific and medical knowledge, competitive intelligence information on latest medical information in order to expand internal literature, databases and library
Triage calls and requests related to safety or adverse event reports according to Prometheus SOP's
Provide medical information and review support regarding all Prometheus products and services to and from clinical affairs, regulatory and commercial teams
Manage clinical investigator relationships to identify and further information exchanges in support of medical affairs
Develop, review & conduct training and education programs for therapeutic and products areas for all internal groups and stakeholders
Assist in development of technical sections of medical and regulatory documents and assist with development and maintenance of medical information, literature and electronic library databases
Able to work as a member of several teams by serving as a key member of clinical affairs and commercial during all phases of development including post marketing
Provide medical/promotional reviews for internal customer groups (such as Sales, Managed Care) as needed
Oversee and maintain literature and standard letter databases to support Prometheus products, including updates, revisions and reported responses
Monitors timely delivery of safety related processes and information for and to clinical development teams and contributes similar data on ad hoc regulatory requests
Designs and executes medical communication plans and information to all internal stakeholders
Oversee coordination with brand teams in developing and implementing superior product and training materials and programs to support educational needs for field teams
Directly supervises the Clinical Development and Medical Affairs Gastroenterology department. Direct reports may include MDs and/or clinical scientists.
EDUCATION and/or EXPERIENCE
Position generally requires an MD degree with a minimum of 10 years of direct experience within the pharmaceutical or biotechnology industry. Subspecialty training and board certification in gastroenterology would be a plus. In depth experience with managing clinical trials and a demonstrated knowledge base in clinical affairs is critical. Previous experience in clinical diagnostic tests and the device industry is helpful but not required. The ideal candidate will have experience in medical information and experience in overseeing field based activities.
Prometheus Laboratories Inc. (Prometheus) is a specialty pharmaceutical company focused on developing and commercializing pharmaceutical and...