Director, Medical Affairs Operations and Excellence

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.

The Director, Medical Affairs Operations and Excellence, will work with the Senior Director, Medical Operations and Excellence to develop and support the Global Medical Affairs (GMA) Technology Strategic Plan that encompasses all systems across all MA regions. Leads strategy, implementation and operation of GMA systems, working in partnership with all related GMA stakeholders (e.g. US Field Medical Team, MAP) and relevant support functions (e.g., IT, Finance). Brings technical and project expertise to execute the Medical Affairs Technology Strategic Plan and ensures plan agreement and implementation. Oversees and manages multiple major projects within the GMA system portfolio to deliver timely and effective data solutions that create significant value across countries, regions and globally.

Responsibilities

• Provides leadership and supports evolution and management of Medical Affairs systems and platforms critical for launch, including, but not limited to, IITs/Grants, Customer Relationship Management (CRM), Medical Plan Tactics and related tools, SharePoint, Advisory Boards, Symposium, etc.
• Develops a system roadmap based on stakeholder needs, technology capabilities, emerging trends, industry practices and data privacy/legal requirements. Keeps stakeholders informed of important changes in each of their respective areas while driving projects within the GMA systems portfolio and roadmap.
• Drives the development of GMA system policies and procedures.
• Responsible for leading and/or participating in operational process reengineering related to GMA systems.
• Partners with other functions to assure the best technology and methods are implemented to manage information consistent with data governance and standards. In conjunction with IS, performs strategic analysis of business needs and proposed technology solutions for new systems.
• Accountable for meeting budget objectives, projects goals, and department priorities.
• Recognizes and anticipates problems. Translates solutions into viable action plans at a global level that are effectively disseminated and implemented through cooperation of stakeholders.

Qualifications

• Bachelor's Degree with a minimum of 10+ years of experience (or advanced degree in related field with a minimum of 7+ years) in executing large, cross functional or global initiatives using a project management framework within business operations.
• Experience within biotech and/or pharmaceutical industry. Vendor management beneficial.
• Demonstrated knowledge of tools used by pharmaceutical industry to support collection of business operations data, such as CRM, SharePoint, etc.
• Excellent planning and organizational skills with strong attention to detail.
• Demonstrated leadership in a matrix organization, able to motivate and inspire team members to high performance levels.
• Proven decision-making skills leading to successful outcomes.
• Demonstrated ability to present complex issues to higher level management and contribute to high level presentations and discussions.
• Demonstrated ability to develop and maintain effective collaborative relationships with team members, management and internal/external partners.
• Demonstrated ability to be a consistent high-level contributor or leader of multiple projects, processes, or functions.
• Ability to present complex issues to higher level management and contribute to high level presentations and discussions.
• Strong communication, conflict resolution, and leadership skills.
• Experience working with teams / individuals with varied cultural backgrounds and learning styles.
• Intermediate to advanced competency and experience with a variety of computer applications, including Microsoft Suite, MS Project, SharePoint and/or other related project management tools.
• Willingness to travel (approximately 20%).

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.