The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the ‘go-to’ organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.
We are currently on the hunt for a Director, Regulatory Affairs (DRA) to navigate researcher teams through the pre-IND and IND filing process for Phase I/II human clinical trials.
As the DRA, you will partner with critical stakeholders (federal, nonprofit, and commercial) to develop and implement robust global regulatory affairs strategy, including expedited pathways for novel therapeutics in humans that emerge from the R&D activities of GTP. Partner with the Regulatory Writer to provide guidance and strategy for all documents submitted to regulators. Acting as the Subject Matter Expert and voice of Regulatory Affairs, you will participate in multi-disciplinary project team meetings and must have the ability to influence non-direct reports. Also, you will monitor current and proposed regulatory, scientific, and pertinent legal issues globally, and perform competitive intelligence to provide an assessment of the impact on product development and IND compliance.
Joining GTP offers professionals the unique opportunity of directly affecting research and discoveries that could one day lead to cures.
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.