Clinical Trial Program Director
The Stem Cell and Gene Therapy Clinical Trial Office (SCGT-CTO) in the Division of Pediatric Stem Cell Transplantation and Regenerative Medicine, Stanford University School of Medicine, seeks a Clinical Development Manager, who will act as a collaborative partner with the Director and faculty leaders to develop, implement, administer, and evaluate long-term objectives and ensure consistency with scientific and clinical goals.
The SCGT-CTO is a specialized entity with expertise in phase I/II clinical trials with cellular products. Stanford School of Medicine strives to lead the biomedical revolution by fueling discovery and innovation to advance human health.
- Provide strategy, vision, and direction; make decisions that implement objectives for the overall operation of the SCGT-CTO.
- Identify, clarify, and resolve issues with strategic impact and substantial significance, which may span 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 and maintain quality control standards, and evaluate program effectiveness.
- Oversee budget and schedule for large programs and/or multiple projects.
- Negotiate with internal departments and external agencies with authority to commit resources and effort.
- Recommend the adoption of emerging technologies and the development of new methods and approaches.
- Liaise with senior management and cross functional areas and schools. Serve as a liaison to external organizations.
- Supervise other staff, including hiring, performance management, and related duties, in addition to providing instruction on complex techniques and direction on projects.
* - Other duties may also be assigned
- Master’s degree in health science related field (i.e. biology, informatics, etc.).
- Experience in phase I/II Clinical Trials design and management.
- Experience in Clinical Regulatory Affairs and Research.
- Knowledge of creating SOPs for the following areas: recruiting and evaluating patients for the assigned clinical research studies, scheduling tests and treatments, monitoring and coordinating patient care, and completing case report forms.
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):
- Demonstrated experience leading and managing technical staff.
- Demonstrated experience leading complex projects or programs.
- Demonstrated ability to work and communicate effectively with others.
CERTIFICATIONS & LICENSES:
- 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.
- Schedule: Full-time
- Job Code: 4987
- Employee Status: Regular
- Grade: M
- Department URL: http://pediatrics.stanford.edu/