Location: UW Department of Pharmacy, Seattle campus, administered through UW Continuum College / Professional & Continuing Education
This is a Senior Lecturer Part-Time. Part-time basis is defined as a minimum of 50% FTE, or quarter-by-quarter up to 100%. The part-time appointment as senior lecturer is for the period stated in the letter of appointment.
General Duties/Description: The successful candidate(s), in consultation with UW faculty and industry advisors, will be responsible for developing and teaching the curriculum for the:
Introductions to Clinical Trials (524)
Implementation & Conduct of Clinical Trials (525)
Project Management & the Business of Clinical Trials (526)
International Regulatory Affairs (527)
Medical risk Analysis & Management (528)
Biomedical Regulatory Affairs Practicum (548)
The senior instructor will develop and deliver a course curriculum that meets the course's stated description and course objectives and will be of a suitable nature to prepare students for further advanced graduate course work in biomedical regulatory affairs, clinical trials and the program's practicum. Senior Instructors are responsible for adhering to UW academic policies. Senior Instructors will need to develop and assess student assignments and other learning activities, and evaluate student performance and set grades. The courses are taught in the evenings so candidates must be available to teach courses at night and be available for student mentoring and office hours.
Qualifications: A doctoral or master's degree in pharmaceutical or biological sciences, bioengineering, relevant product development experience in medical products regulatory affairs, with substantial industrial experience in biologicals, pharmaceuticals, and/or medical devices. The candidate must demonstrate the ability to develop and teach the core content within this specialty and demonstrate an ability to recruit guest lecturers and UW faculty members to deliver the courses' curriculum content. Experience in teaching or training adult, working, professional learners is highly preferred. The ideal candidate will have at least ten years of medical product industry experience and have a solid and broad understanding of the entire drug, biologic or medical device development process from discovery through to regulatory submission and post-market surveillance. The candidate must demonstrate a comfort level in using and learning to incorporate a variety of computer software and instructional technologies. Candidates must meet the educational and professional criteria to receive part-time senior lecturer or affiliate faculty appointments, as required by the UW Graduate School for instructors teaching in graduate level courses. The content for program's courses must include:
PHRMRA 524 Introduction to Clinical Trials (3 credits) Wednesdays, 6:00-8:50pm, Autumn quarter. Introduces the major concepts under which clinical trials are designed to run. Focuses on the phases of clinical trials, the role of the Food and Drug Administration, Institutional Review Boards, the Code of Federal Regulations and ethical principles. Addresses study design and statistical concepts.
PHRMRA 525 Implementation and Conduct of Clinical Trials (3 credits) Wednesdays, 6:00-8:50pm, Winter quarter. Outlines the work of carrying out a clinical trial including the complex work of study initiation, issues of site and data managements, preparation of the final report and study close out, as well as the details that control the study conduct.
PHRMRA 526 Project Management and the Business of Clinical Trials (3 credits) Wednesdays, 6:00-8:50pm, Spring quarter. Addresses the business dimension of clinical trials, including the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study.
PHRMRA 527 International Regulatory Affairs (3 credits) Thursdays, 6:00-8:50pm, Autumn quarter. Develops an understanding of international differences in the regulation of design, manufacture, and post-marketing surveillance of medical products relative to U.S. Food and Drug Administration requirements.
PHRMRA 528 Medical Risk Analysis and Management (3 credits) Tuesdays, 6:00-8:50pm, Autumn quarter. Examines the principles and application of risk management methods in the design, manufacture, and marketing of medical products.
PHRMRA 548 Biomedical Regulatory Affairs Practicum ([1-9 credits]-, max. 9 credits) Autumn-Summer quarters. Provides a practical experience to ensure that participants are able to shepherd new medical products (drug, device, biologic) through regulatory, clinical, and quality assurance aspects. Includes a project and final report.
Compensation: Commensurate with education and/or experience.
Successful candidates will find a diverse Department (47 faculty with over 400 Adjunct, Affiliate and Clinical faculty) with nationally recognized expertise in health economics, outcomes research, health policy evaluation, pharmacogenomics, pharmacoepidemiology, translational research, and therapeutics. The UW has perennially ranked in the top 3 nationally for federal research funding and received over $1.3 billion in sponsored research in FY2015. The School of Pharmacy is ranked #1 nationally for Schools of Pharmacy in research funding per faculty and The Chronicle for Higher Education ranked the School of Pharmacy research programs as
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.
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