Job Posting Title:

Job Description:

Position Overview:

Faculty, Part-time, Exempt

KGI is seeking applications for a part-time position in regulatory affairs. The successful candidate will join the Henry E. Riggs School of Applied Life Sciences at KGI (Riggs) conducting teaching and curriculum development in regulatory affairs. The Riggs School prioritizes teaching and research. The 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. This position will support the existing portfolio of 15+ courses in Clinical and Regulatory Affairs, supporting existing KGI degree programs.

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 and certificates that integrate life and health sciences, business, pharmacy, engineering, and genetics, with a focus on industry projects, hands-on industry experiences, and team collaborations. Within KGI, the Riggs School employs an entrepreneurial approach and industry connections that provide pathways for students to become leaders within the life science industries. Its flagship Master of Business and Science degree program has graduated more than 900 students, most of which are now pursuing successful careers in pharmaceutical, biotechnology and other biomedical companies. Active learning and the involvement of industry in educational projects are hallmarks of teaching within the school.

KGI is a member of the Claremont Colleges, a consortium of five undergraduate liberal arts colleges and two graduate institutions. 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, faculty, and distinctive mission, and each offers top-notch curricula, small classes, distinguished professors and personalized instruction. Located in beautiful Claremont, California, the community combines a college town experience with excellent public schools and easy access to downtown Los Angeles.

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 Duties and Responsibilities: Individuals must possess knowledge, skills and abilities to perform the essential functions 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  clinical and regulatory curriculum.
• Work with 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.
• Evaluate and advise 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 perform the essential functions 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.

Hours, Classification, and Status: 

This is a Faculty, part-time, exempt position, with benefits eligibility determined by the assigned FTE. 

Work hours for this part-time position will vary based on FTE, course schedules, and departmental needs and may fall within standard business hours, Monday through Friday, 8:00 a.m. to 6:00 p.m.

Salary range: $50,000–$60,000 annually, aligned with the assigned effort (FTE) for this part-time position. Final salary will be determined based on a variety of factors, including internal equity, experience, education, specialty, and training.

KGI offers a comprehensive compensation and benefit package. To learn more, visit https://services.claremont.edu/benefits-administration/ 

Physical and Mental Requirements

Ability to maintain good concentration level while dealing with interruptions; attention to detail 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.  Standing for extended periods of time. Reaching and extending hand(s) or arm(s) in any direction.  Finger dexterity is 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 lift and carry short distances up to 20 lbs., for example to lift or move office supplies, files, books and packages. Ability to travel locally and travel by airplane nationally, depending on business needs. Occasionally, will be required to stand for prolonged periods of time at activities/events on and off-campus. May require overnight stays. 

To Apply:

A confidential review of applications, nominations, and expressions of interest will commence immediately and continue until the position is filled. For full consideration, please submit the following:

• A cover letter detailing your professional experience and qualifications
• A comprehensive curriculum vitae outlining academic and professional achievements
• Contact information for three professional references, including name, title, relationship to the applicant, email address, and direct phone number
• A statement of teaching philosophy

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.

Keck Graduate Institute (KGI) is a participating employer in E-Verify. We use E-Verify to confirm the employment eligibility of all newly hired employees as required by federal law. For more information about E-Verify, please visit www.e-verify.gov.