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.
Provide strategy and vision; make decisions that establish objectives for the overall direction or operation of a significant project(s) or area(s).
Manage staff of a large science, engineering, and/or technical research area, which includes recruiting, hiring, developing, evaluating and setting priorities; manage business, technical, and educational activities for direct reports including managers and technical experts.
Identify, clarify, and resolve issues with strategic impact and substantial significance, which spam multiple areas, using advanced technical and professional knowledge requiring broad discretion and judgment.
Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives.
Develop policies and procedures as they relate to academic or program activities.
Implement, evaluate and maintain quality control standards to ensure program success.
Establish, oversee and manage financials and schedule for large programs and/or multiple projects.
Recommend the adoption of emerging technologies and the development of new methods and approaches.
Negotiate with internal departments and external agencies with authority to commit resources and effort.
Serve as a liaison to senior management, cross-functional areas, schools and external organizations such as sponsors and government agencies.
* - Other duties may also be assigned
DESIRED QUALIFICATIONS: Advanced degree preferred and demonstrated expert knowledge & up-to-date familiarity with regulations pertaining to INDs involving CBER and ICH guidance including experience with CMC development in cell and gene therapy. EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree and eight years of relevant experience or combination of education and relevant experience. Advanced degree may be required.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
Experience leading, managing, motivating and developing technical staff.
Experience leading complex scientific, engineering or technical research projects or programs.
Detailed understanding of relevant business and technical knowledge and problem resolution.
Ability to synthesize and articulate technical and scientific methodologies, specifications, and information.
Knowledge of emerging technologies, trends, methodologies, and resource management principles.
Demonstrated ability to work and communicate effectively with others.
Exceptional customer relationship and consensus building skills.
Ability to influence and establish effective working relationships in a diverse environment.
Ability to resolve complex issues quickly and make decisions that meet university objectives in a collaborative culture.
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. Additional PHYSICAL REQUIREMENTS: (remove if none) WORKING CONDITIONS:
May require extended hours, evenings and weekends.
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.
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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.