Director, Regulatory Program Management

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.

The Director will be responsible for assuming oversight of AveXis' Regulatory Portfolio Management for clinical and commercial regulatory submissions, both in the US and ex-US. This position will also be responsible for contributing to creation and oversight of Regulatory procedures and processes.

They will establish AveXis regulatory submissions process and tools, risk assessment, mitigation, and strategic planning, with regards to resources, cross-functional plans and timelines across all programs, ensuring that Clinical Development, Regulatory, Medical Affairs, and Manufacturing ensuring that integrated timelines are established, and strategies are aligned. This role serves as the intermediary between these functions, and the Project Teams, working through issues and ensuring that functional plans are harmonized, and critical decisions are made in a timely manner.

This position will work across all development programs within AveXis, managing and tracking the entire portfolio, across projects and geographies.

Responsibilities

• Assume oversight of internal Program Management for Regulatory Affairs and Regulatory Submissions.
• Oversee one or more Regulatory project managers.
• Ensuring adequate regulatory coverage for all programs within the AveXis portfolio.
• Collaborate with Team members to establish effective, productive relationships with key internal individuals, including but not limited to the clinical, non-clinical and manufacturing organizations.
• Partner closely with the Regulatory organization to shape the Program strategy, goals and plans to ensure close alignment.
• Build and maintain detailed project plans for all programs across the AveXis portfolio.
• Ensure various programs remain on track; own the timelines without any deviation.
• Drive team effectiveness by setting and communicating clear expectations on deliverables, roles and responsibilities, and by promoting team cohesiveness.
• Proactively identify potential issues and work to remove barriers; escalate issues appropriately that cannot be resolved by the team.
• Partner closely with SVP Regulatory Affairs to ensure flawless execution of regulatory programs.

Qualifications

• Undergraduate degree in an area related to life sciences. Graduate degree such as a PhD, PharmD, or MBA is highly desired; a PMP designation is preferred. A minimum of 15+ years of experience with in the biotechnology/ pharmaceutical industry, preferably in a company focused on orphan or rare disease drugs.
• A minimum of 10 years of experience in the Program/Project Management of complex cross-functional biotechnology/pharmaceutical product development projects with aggressive milestones in the regulatory environment.
• Knowledge of drug development and manufacturing processes.
• Exposure to the success and failure of drug candidates; ability to be creative and think outside of the box regarding the path to commercialization.
• An innovative thinker, with a track record for translating strategic thinking into action plans and output.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
• An excellent and persuasive communicator.
• Energetic, flexible, collaborative and proactive; a team leader who can positively and productively impact initiatives.

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.

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