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Location: Plymouth Meeting, PA

Type: Full time

Company Overview

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.

Position overview

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.

Key Responsibilities

• Provide overall leadership and regulatory guidance that shapes the direction of iECURE’s programs
• Lead regulatory strategy with pediatric division of global regulatory agencies
• Develop strategy to enable expedited submission of BLA and minimize agency’s review timelines for clinical candidates (e.g., Breakthrough Designation, Prime Designation, Orphan Drug Designation, Pediatric Designation)
• Serve as an influential leader and develop strong and productive working relationships with key stakeholders
• Conduct a process to select the appropriate regulatory consulting firm to support global regulatory IND/CTA submissions
• Represent the regulatory function in each of the clinical program’s Project Team meetings, informing the Project Team as to the status of key tasks
• Collaborate with Project Management Team members to develop and execute global regulatory strategy that accelerates timelines for approval
• Participate in the Quality Board ensuring iECURE’s quality programs are maintaining GxP standards
• Oversee and lead the preparation of effective, persuasive presentations to regulatory authorities
• Create clear and concise documents regarding regulatory strategy for senior management
• Provide strategic direction regarding dossier content to ensure that knowledge of the drug, disease, regulatory requirements, and idiosyncrasies of regulatory authorities are incorporated
• Review protocols, study reports, and all types of regulatory documentation (e.g., quality, safety, efficacy)
• Hire, develop, and lead a strategic team to build the organization as it evolves through approval, prelaunch, and launch activities
• Ensure representation as needed in governance or strategic teams or committees
• Remain at the forefront of the relevant science and competitive landscape including detailed competitive intelligence and be viewed as an expert in its application to the regulatory process
• Partner and provide guidance on Penn’s regulatory activities to produce the most efficient and effective outcomes possible for iECURE

Requirements

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.

Qualifications

• BA/BS required, advanced degree in a life science or related discipline preferred (e.g., PhD, PharmD, MSc, MBA)
• A minimum of 10 years of regulatory affairs experience, ideally gained from a mix of both large and small companies
• Experience working with cell and gene therapies and/or rare diseases is preferred. Other therapeutic areas will be considered if the individual has experience defining and designing novel regulatory pathways
• Experience with global regulatory agencies on submission for pediatric indications
• A prior track-record of successful regulatory delivery, with IND/CTA and NDA/BLA submission experience
• Deep knowledge which reflects current regulatory guidelines and practice, including electronic submissions
• Ability to balance corporate goals with the current regulatory requirements
• Possess a high level of credibility and relationships with the FDA and other international regulatory authorities
• Comfortable brainstorming and collaborating with executives and members of the team, and encompassing the ability to translate ideas into more detailed strategy
• Outstanding written and communication skills to include experience in authoring both internal and externally facing regulatory related documents
• Demonstrable experience of working hands-on with limited resources
• Ability to think at a strategic, big-picture level and delve into details when appropriate
• Positive attitude and change agent capable of working and leading others in a matrix environment
• Proficient at approaching problems/risks/issues with professionalism, confidence, and decisiveness with the ability to provide resolutions

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.