SCIENTIFIC PROGRAM MANAGER
Duties: This position reports to the CCI Director for Translational Sciences Operations to support CCI initiated Clinical Trials. This position is providing support in translational, regulatory, and operational aspects for the initiation, conduct, overseeing, and data analysis of CCI Trials, to provide leadership and management to move candidate gene therapy products into the clinic. The clinical trials include first in humans through Phase II clinical development. The Scientific Program Manager will work in a highly cross-functional environment to cultivate relationships with Penn internal and external (other institutions, foundations, and bio pharmaceutical) groups, with CCI functional groups to determine the progress and check points for moving new targets into clinical studies, or for completion of human samples analysis, or for coordinating the optimization of cell product manufacturing processes. The Scientific Program Manager will also interact with clinical personnel for the development of clinical protocols and other regulatory documents. The Scientific Program Manager will provide project specific leadership driving trial timelines, and participate in the management of intellectual property. More specifically, the Scientific Program Manager will be involve in generating and driving the regulatory strategy and potentially serving as IND sponsor designee, summarize preclinical data for regulatory submissions, prepare regulatory documentation, author and contribute to scientific and clinical manuscript development.
Qualifications: The minimum of a Masters degree and 3 to 5 years of accumulated experience in cancer biology and /or translational research for oncology applications, or an equivalent combination of education and experience, are required. PhD is a plus. Laboratory experience is essential. Strong writing, analytical, and communication skills are mandatory. Familiar with GLP, ability to accurately work under deadline pressure, administrative, and managerial skills are preferred. Superior computer skills with MS Word, Excel, PowerPoint project, graphics, and a reference manager are required. Position is contingent upon funding.
Reference Number: 40-27404
Salary Grade: 028
Employment Type: Exempt
Org: CI-Center for Cellular Immunotherapy
Job Family: B-Executive/Managerial Administration