Clinical Trial Therapy Specialist

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 (ZOLGENSMA®). 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.

AveXis is seeking a pediatric physical or occupational therapist to provide support to the existing therapy function within Clinical Operations. This role will work closely with various members of the Clinical Operations department to support multiple clinical development programs. This will be a fast-paced role within a ground-breaking clinical development program requiring the individual to be highly motivated, organized, solution-oriented, and efficient.

Responsibilities

• Participate in development of departmental Standard Operating Procedures (SOPs), guidance, templates, and forms while ensuring adherence to ICH-GCP and global regulations.
• Assist in identifying and evaluating qualified vendors or consultants to support physical assessment requirements as they relate to clinical studies.
• Assist and collaborate in development of project-specific workflows and procedural documents when necessary, pertaining to physical assessments including operational procedure manuals, documents, forms, etc.
• Ensure consistency of practices and procedures implemented across development programs.
• Review study patient videos on an ongoing basis using web-based platforms/workflows to assist in determining sufficient documentation to support achievement of developmental milestones.
• Coordinate program/study review of patient videos by AveXis physician team and/or independent central reader in web-based platform.
• Assist investigative site clinical evaluators, as necessary, with problem solving for video uploads in web-based platform and other technology.
• Actively suggest means to increase efficiency and other improvement measures.
• Assist in planning, coordination, and conducting of site clinical evaluator training/qualification and ongoing maintenance of therapist reliability.
• Coordinate program/study clinical evaluator training and material preparation, reliability activities, and participate in/coordinate Investigator meetings as necessary.
• Produce and maintain documentation and records to support the activities of site clinical evaluators and study patients in accordance with departmental SOPs.
• Use a wide range of communication channels to engage and communicate with team members, colleagues, and site members.
• Participate in process improvement initiatives as requested.

Qualifications

• Holds a Doctorate or master's degree in physical or occupational therapy with 5+ years pediatric clinical experience with birth to age 5 population.
• Valid physical or occupational therapy license.
• Self-motivated with strong interpersonal, team, and collaboration skills.
• Must display effective planning and organizational skills, innovativeness, and keen attention to detail with excellent written and verbal communication skills and follow through.
• Ability to identify risks/challenges, engage in problem solving and proposing solutions, and act towards resolution.
• Global travel a few times annually (
• Proven ability to manage multiple high-level parallel tasks, work unsupervised, have effective computer skills, possess the ability to apply new techniques, and be able to prioritize tasks and skills.
• Desire and ability to work in a fast paced, dynamic start up environment.

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.

#LI-EC1