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We follow the science that will lead us to the best possible outcomes for patients.
We are a mutation-agnostic in vivo gene editing company striving to cure liver disorders with high unmet needs by harnessing new advancements in genetic medicine. Our in vivo insertion methods knock in healthy copies of disease-causing genes, offering long-term, stable expression of those genes in patients.
Our science is at the leading edge, and so are we. Our team of experts is here to transform lives and bring potentially curative treatments to patients in need. Great work takes a deep level of collaboration at all levels, and we strive every day to foster an environment that inspires innovation, execution and an unrelenting commitment to patients.
We are built on the world-class translational engine at the University of Pennsylvania’s Gene Therapy Program (UPenn GTP). The work executed by this group of world‑renowned gene therapy experts on our pipeline provides a substantial developmental head start – meaning treatments in the hands of patients as quickly as possible.
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VP, Head of Regulatory Affairs
Location: Plymouth Meeting, PA
Type: Full time
iECURE (pronounced EE-ah-cure) is a preclinical stage gene editing company focused on developing therapies that utilize mutation-agnostic in vivo gene insertion, or knock-in, therapy for the treatment of monogenic liver disorders with significant unmet need. iECURE’s approach has the potential to replace and restore the function of a dysfunctional gene by knocking-in a healthy copy, regardless of mutation, to offer durable gene expression and long-term, potentially curative, therapeutic benefit.
The company is collaborating with the University of Pennsylvania’s (Penn) Gene Therapy Program (GTP), led by Dr. James Wilson, to utilize the GTP’s world-class translational expertise and infrastructure, which has helped generate our initial pipeline of product candidates. The Penn collaboration provides iECURE with the exclusive right to develop up to 15 product candidates each focused on a liver indication; we have nominated three product candidates to date, which comprise our initial pipeline.
With preparations underway to translate pre-clinical work from Penn’s GTP to the clinic, as well as ambitions to build out a manufacturing capability, iECURE is seeking a Head of Regulatory Affairs (RA) to join its senior leadership team.
The successful candidate will be strategic-minded, diplomatic and a highly experienced regulatory affairs leader who can work effectively with the founding scientific team at Penn to provide strategic guidance on IND submissions and support on translating the pre-clinical package into the clinic under the stewardship of iECURE. This individual will also play a key role in defining the company’s regulatory strategy across its pipeline and providing regulatory CMC support.
iECURE is seeking a seasoned professional who has held the lead role in a company defining the regulatory strategy associated with all phases of drug development, including the coordination and preparation of document packages for regulatory submissions. This individual will have a strong rapport and collaborative relationship with the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide.
Aside from technical capabilities, this individual will have outstanding presentation, oral and written communication skills, as well as an enthusiastic and open attitude toward learning and continuing professional development. Evidence of the ability to achieve results, both independently and in a team, is required in addition to being able to navigate a dynamic and fast-paced work environment.
iECURE, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.