Professor of Practice, Regulatory Affairs, Henry E. Riggs School of Applied Life Sciences

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.

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.

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