Job description

Duties: The responsibility of a Director in the Sponsor Support Unit of the Office of Clinical Research is to assume regulatory responsibility for University and faculty held Drugs and Biologic Therapies (INDs) and Devices (IDEs) foreign clinical trial applications (CTAs). The Director is charged with the development and execution of the regulatory strategy, risk mitigation and lifecycle management support for University and PSOM faculty held INDs/IDEs/CTAs; thereby ensuring the safe use of investigational drugs and biologics and devices and adherence to US state, federal and international regulations and guidances governing the development of these products. In certain circumstances, the existing regulatory guidance will not cover the scope of the research, and novel approaches will be required to implement the proposed study. The Director will play a lead role in discussions with international and US regulatory agencies and funding bodies in the development of guidance for these studies. When needed, the Director will provide guidance and support for other therapies and devices. The responsibilities for this position include the coordination and facilitation of meetings with the FDA, Health Canada, and other regulatory agencies, collaborators and funding agencies and the preparation and submissions of regulatory documents to global regulatory bodies. The Director will provide guidance on pre-clinical pharmacology and toxicology studies and investigational product manufacturing standards and practices. This position will work in partnership with current Unit leadership in the direction of OCR and management of the Sponsor Support Unit team, which includes one Director, one Senior Associate Director, two Associate Directors, five Regulatory Affairs Specialists, and three Senior Monitoring Specialists. This position includes responsibilities for staff supervision and training, workload assignment and staff development.

Qualifications: The minimum of a Master's degree and 7 to 10 years of experience in the pharmaceutical/biotechnology industry or an equivalent combination of education and experience required. PhD in a scientific discipline and/or MD preferred. At least 7 years experience with strategic regulatory management of drug and biologic development and/or marketing authorizations for devices required; Extensive experience in clinical development from pre-IND/IDE/CTA to NDA/BLA/PMA/510k required; Experience in academia or industry in scientific discovery and pre-clinical development preferred; Thorough working knowledge of the regulatory requirements and processes for adherence is necessary. Comprehensive working knowledge of the ICH guidelines, as well as comprehensive understanding of the application of the Federal principles of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) are essential.

Reference Number: 40-25578

Salary Grade: 031

Employment Type: Exempt

Org: SM-DN-Office of Clinical Research

Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

Job Family: B-Executive/Managerial Administration




Diversity Profile: University



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Job No:
Posted: 4/19/2017
Application Due: 4/19/2018
Work Type: