Vice President, Regulatory Affairs Non-Clinical

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

This position is responsible for the overall strategy and oversight of the Regulatory Affairs Non-Clinical Development function. This position will also build the department to support the expanding pipeline of products in development. This individual will provide leadership and work closely with other areas within regulatory affairs as well as the Toxicology, Pharmacology, and pre-clinical development functions.

Responsibilities

• Provide Leadership and oversight of the Non-Clinical Regulatory Affairs department.
• Provide regulatory strategy in design of non-clinical development programs and IND enabling studies.
• Determine overall regulatory strategy regarding early stage clinical protocol development.
• Work closely with cross functional teams to ensure development programs are aligned with clinical and commercial needs.
• Build a department to support an expanding pipeline of products in development and on the market.
• Work closely with other functions within Regulatory Affairs.
• Initiate and maintain effective partnerships with key functions (Toxicology, Pharmacology, Clinical Development).
• Develop and execute sound regulatory decisions and justifications.
• Provide direct supervision of individuals including mentoring, performance management and staffing decisions.

Qualifications

• Bachelor's degree or country equivalent. Higher degree will be an advantage; Minimum 20+ years in pharmaceutical industry, with increasing levels of expertise/experience.
• 15+ years of experience in Regulatory Affairs.
• International experience/exposure preferred.
• Proven regulatory leadership experience in a cross-functional role with significant product development experience.
• Established understanding of non-clinical development programs.
• Strong technical knowledge of non-clinical development.
• Strong knowledge and interest in the evolving landscape of novel clinical development programs.
• Experience with rare diseases preferable.
• Experience with breakthrough therapy designation products preferable.
• Experience leading transformational change within an organization is highly desirable.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.