The Laboratory for Cell & Gene Medicine (LCGM) at Stanford University is seeking an Associate Director of Regulatory Affairs who will be responsible for overseeing and implementing Regulatory Affairs strategies and activities relating to all Stanford School of Medicine investigator-initiated INDs, from initial filing for clinical trials in the setting of an academic research organization and for a cGMP (current Good Manufacturing Practice) facility. The position will assist in the development and implementation of regulatory strategies for interacting with regulatory agencies, will act as liaison with the FDA, NIH-OBA, and institutional regulatory committees. This position will provide staff expertise and preparatory assistance to Regulatory Affairs management in preparation of documents for Regulatory submissions to the FDA for assigned clinical trials. This role is collaborative in nature and interacts regularly with all other functional groups including Process Development & Manufacturing, Quality Systems, Operations and Finance & Administration. The Laboratory for Cell and Gene Medicine (LCGM) is a ~25k ft2 multi-product biologics manufacturing facility that provides regulatory, quality systems, process development and manufacturing support to the School of Medicine, Lucile Packard Children's Hospital (LPCH) and Stanford Health Care (SHC) in developing innovative cell and gene-based therapies for clinical trials aimed at treating disease and the promotion of health in pediatric and adult patients. Duties include:
Make decisions independently regarding projects, programs, and initiatives within confines established by management.
Clarify and resolve issues with substantial significance and impact, which may span multiple areas, using advanced technical and professional knowledge.
Monitor and evaluate completion of tasks and projects. Oversee interdepartmental activities and efforts.
Manage project budgets, schedules, and resources; lead planning activities for assigned area.
Oversee preparation of periodic financial and technical reports and operating plans.
Interface with customers to determine project requirements.
Select, develop, and evaluate personnel to ensure the efficient operation of the function.
Supervise other staff, including hiring, performance management, and related duties, in addition to instruction on complex techniques and direction on projects. * - Other duties may also be assigned
Advanced degree preferred
3 to 6 years with a Masters, or 2 to 3 years with a PhD, and demonstrated working knowledge of scientific principles. Up to date familiarity with regulations pertaining to INDs involving CBER and ICH guidance, including experience with CMC development in cell and gene therapy
Certificate or training in Regulatory Affairs
Preferred Field of Expertise
Regulatory Affairs or relevant scientific field EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree plus five years of relevant experience, or combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Demonstrated experience leading and managing technical staff.
Demonstrated experience leading large projects or programs.
Demonstrated ability to work and communicate effectively with others.
Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
Occasionally sit, use a telephone or write by hand.
Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Location: School of Medicine, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
Copyright 2017 Jobelephant.com Inc. All rights reserved.
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.