Program Director, Master of Science in Regulatory Affairs
Job Posting Title: Program Director, Master of Science in Regulatory Affairs
Keck Graduate Institute (KGI) was founded in 1997 as the first higher education institution in the United States dedicated exclusively to education and research related to the applied life sciences. KGI offers innovative postgraduate degrees that integrate life and health sciences, business, pharmacy, engineering, and genetics, with a focus on industry projects, hands-on industry experiences, and team collaborations. KGI employs an entrepreneurial approach and industry connections that provide pathways for students to become leaders within healthcare and the applied life sciences. Hundreds of successful students have graduated from our two industry focused graduate programs, the Master of Business and Science and the Master of Engineering in Pharmaceutical Processing, most of which are now pursuing successful careers in the bioscience industries. Active learning and the involvement of industry in educational projects are hallmarks of teaching within the school. The Amgen Bioprocessing Center (ABC) is a collegial center within KGI, offering world-class educational experiences to students at Masters and PhD level. The ABC is growing rapidly as part of a broader strategic initiative within KGI to expand the size and impact of its educational programs.
Located in beautiful Claremont, California, Keck Graduate Institute is a member of the Claremont Colleges, a consortium of five undergraduate liberal arts colleges, two graduate institutions, and The Claremont Colleges Services, which provides shared institutional support services. The Claremont Colleges consistently place at the top of national college rankings, including Forbes, Money and U.S.News and World Report and the Princeton Review. Each nationally recognized college has its own campus, students and faculty, and distinctive mission, and each offers top-notch curricula, small classes, distinguished professors and personalized instruction.
Keck Graduate Institute (KGI) of Claremont, California is seeking to hire the inaugural program director for its new Master of Regulatory Affairs (MSRA) degree program. The program director will be responsible for overseeing the launch and growth of the MSRA program, as well as for teaching courses that serve both MSRA and other KGI students. The position will also include appointment to a faculty position consistent with KGI policies.
Scheduled to launch in Fall 2021, the MSRA program is being offered jointly by KGI and the Beckman Research Institute of the City of Hope, a National Cancer Institute-designated comprehensive cancer center and a national leader in advancing research and treatment protocols. The first year curriculum at KGI provides an interdisciplinary perspective on drug development, supplementing clinical and regulatory courses with science and business courses tailored to careers in pharmaceutical companies. The second year will include two semester-long regulatory rotations at City of Hope, clinical trial protocol development, regulatory filings and otherwise supporting the institute's clinical research activities.
The new director will also oversee and grow KGI's existing portfolio of 15+ courses in Clinical and Regulatory Affairs, supporting both the MSRA and existing KGI degree programs. The latter includes KGI's unique interdisciplinary Master of Business and Science program, with more than 700 alumni working in life science, consulting and healthcare organizations. The director is expected to join KGI on or before August 1, 2021.
Education and Experience:
The successful candidate will have extensive experience in one or more of the following areas: clinical research, regulatory affairs, or quality assurance. Industry experience in the areas of drugs and biologics, cell and gene therapies, medical devices, and/or diagnostics is preferred.
Experience with the FDA is required, while experience with non-US regulatory bodies is highly desirable. A minimum of 10 years of industry experience in clinical, regulatory and/or quality assurance.
Essential Functions and Responsibilities: Individuals must possess knowledge, skills and abilities to successfully perform the essential function of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.
Provide vision and oversight for the design, implementation and evaluation of MSRA and other clinical and regulatory curriculum
Work with City of Hope and other potential partner sites to align curriculum and rotations to each other and to program outcomes
Work with other KGI faculty, to coordinate the content and delivery of clinical/regulatory courses serving the MSRA and other programs
Evaluate and advise MSRA and other clinical/regulatory students
Support efforts to attain and maintain appropriate accreditation for programs related to clinical and regulatory affairs
Help recruit and evaluate qualified clinical and regulatory faculty
Engage in active scholarship and service
Perform other duties as determined by the department chair or dean
Required Knowledge, Skills and Abilities: Individuals must possess knowledge, skills and abilities to successfully perform the essential function of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.
A minimum of 10 years of industry experience in clinical, regulatory and/or quality assurance
Demonstrated experience and expertise in regulatory standards for approval, manufacturing and/or use of parenteral regulated medical products
A graduate degree in a life science field is preferred
Experience working with (or within) one or more regulatory agencies
Excellent oral and written communication skills
Experience developing and mentoring current and potential industry talent
Strong organizational skills and ability to manage multiple simultaneous projects and tasks
Prior teaching experience is desirable
Physical and Mental Requirements:
Ability to maintain good concentration level while dealing with interruptions; attention to details with emphasis on accuracy; capable of giving, receiving, and analyzing information, formulating work plans, and articulating goals and action plans. Sitting in a normal seated position for extended periods of time, particularly related to the use of a computer. Standing for extended periods of time. Reaching and extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than the whole hand(s), or arm(s), for example, using a keyboard. Communication skills using the spoken word. Ability to see within normal parameters. Ability to hear within normal parameters. Ability to bend and stoop, for example, to file. Ability to move about. Ability to lift and carry short distances up to 20 lbs., for example to lift or move office supplies, files, books and packages.
Ability to drive locally and travel by airplane nationally. Occasionally, will be required to stand for prolonged periods of time at activities/events on and off-campus.
A confidential review of applications, nominations, and expressions of interest will begin immediately and will continue until an appointment is made. To be ensured full consideration, please submit a cover letter highlighting your professional experience; a complete CV outlining your career and educational credentials; and three professional references (including their names, relationship to you, their position, email, and direct phone numbers). Minority candidates are strongly encouraged to apply.
Equal Employment Opportunity Policy
Keck Graduate Institute is an equal opportunity employer. It does not discriminate against qualified employees or applicants based on race, color, religion, sex, gender identity, pregnancy, national origin, ancestry, citizenship status, age, marital status, physical disability, mental disability, medical condition, sexual orientation, military or veteran status, genetic information, or any other characteristic protected by applicable state or federal law. Equal employment opportunity will be extended to all persons in all terms and conditions of employment. KGI strongly encourages candidates from underrepresented groups to apply.