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Posted Job Title
Scientific Program Lead
Job Profile Title
Manager Research Project B
Job Description Summary
This position resides within Translational Sciences Operations to support CCI initiated clinical trials. This position provides support in translational, regulatory, and operational aspects for the initiation, conduct, oversight and data analysis of CCI trials to provide the direction and management needed to move candidate gene therapy products into the clinical setting. The clinical trials include first in human Phase I studies.
The Scientific Program Lead will work in a highly cross-functional environment to determine the progress and checkpoints for moving new targets into clinical studies.Â The Scientific Program Lead will interact with CCI laboratories and cell therapy manufacturing facility in relation to completion and assessment of human sample analysis and for coordinating the optimization of cell product manufacturing processes.Â The Scientific Program Lead will also interact with clinical personnel for the development of clinical protocols and other regulatory documents.Â The Scientific Program Lead will provide project specific support to drive trial timelines.Â More specifically, the Scientific Program Lead will be involved in supporting the regulatory strategy and participating as a member of the core IND Sponsor team, and will be expected to summarize preclinical data for regulatory submissions, prepare regulatory documents, author and contribute to scientific and clinical manuscript development.
Position is contingent upon funding.
Master's Degree with 3-5 years of related experience OR Bachelor's Degree with 5-7 years of related experience required.
Ph.D. is preferred.
The successful candidate will have knowledge in the field of cell and gene therapy, and will be familiar with early-stage clinical trial design.
Strong writing, analytical, and interpersonal skills are a must and candidate should be comfortable giving scientific presentations to a scientifically diverse audience.Â
The candidate must be proficient in Microsoft Office suite (Word, Excel, PowerPoint, Project) as well as reference manager software (EndNote preferred) and data analysis/presentation programs (i.e.GraphPad).
Working Conditions Office, library, computer room
Physical Effort Typically sitting at a desk or table
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00016767
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.