Essential Duties Overview:

• Provide endocrinology expertise to clinical trials in the drug and device development process
• Review and edit protocols to ensure accuracy, consistency with standard of care, logistical ease and internal consistency
• Develop, plan and implement clinical research direction and vision that are in support of corporate goals and timelines
• Manage and approve the establishment of scientific methods for design and implementation of clinical protocols, data collection and final reports
• Provide clinical expertise to development project teams and assume leadership role, as appropriate, in providing clinical guidance to development, marketing and operations groups
• Provide scientific and medical expertise in support of business development activities and maintain close working relationships with R & D clinical groups, operations and marketing staff
• Provide operational support to team in clinical trial planning, protocol development, investigator selection, training of internal and external personnel, medical monitoring for trial safety and quality control
• Provide consistent and appropriate medical monitoring to ensure patient safety and adequate reporting and coding of adverse events in clinical trials
• Write and edit clinical reports for regulatory submission and updates consistent with medical accuracy
• Support clinical staff for review of product complaints, MDR reporting criteria, health risk assessments and product performance criteria

Overview of Requirements:

• Medical degree (M.D. or D.O.) and current license to practice medicine in Endocrinology, board certification preferred, board eligibility accepted OR demonstrated experience/expertise in metabolic drug development or R & D experience in related medical fields

• Medical degree (M.D. or D.O.) and current license to practice medicine in Endocrinology, board certification preferred, board eligibility accepted OR demonstrated experience/expertise in metabolic drug development or R & D experience in related medical fields
• Clinical experience in endocrinology including experience in the pharmaceutical industry
• Clinical research experience both outside and within the industry including multi-center trials
• Understanding of the drug development process, clinical operations, marketing principles and strategies

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