Director, Medical Communications (Pipeline Products)

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.

AveXis is seeking a Director of Medical Communications who will ensure that medical and scientific results from AveXis studies are communicated in an accurate, timely, compliant and compelling manner with a focus on our pipeline products. The position will also be accountable for the development publications, including meeting abstracts, medical materials and resources for internal medical and field medical team content for medical meetings/symposia, advisory board materials, and content for internal medical affairs education. The successful candidate will be responsible for the development and implementation of the strategic global medical communication and publication plan to support our pipeline products.

Responsibilities

• Responsible for a strategic and impactful medical communications plan through consolidation of input from appropriate stakeholders on AveXis early phase programs.
• Lead the development and implementation of a scientific communication platform, in collaboration with the global medical affairs team, the publication lead, and other cross-functional stakeholders.
• Serve as the Medical Affairs lead for global congress strategy, planning and execution in the development of medical education content for ALS and Rett Syndrome focused congresses and medical communication activities (e.g., congress medical booth materials and planning).
• Responsible for leading the strategy and executing key medical communication deliverables and activities related to ALS and Rett Syndrome focused symposia and other medical education.
• Contribute to planning and the development of materials to lead Rett Syndrome and ALS related roundtables and advisory boards.
• Lead the development of product and disease state slide decks to support field and internal medical team education on the ALS and Rett Syndrome programs.
• Lead the collection and dissemination of key insights and competitive intelligence from ALS and Rett Syndrome related congresses, symposia, advisory boards and stand-alone meetings.
• Perform critical analysis and synthesis of internal/external scientific data.
• Lead the agenda development, content creation, and execution for educational symposia and internal meetings/summits. Ensure alignment of with the cross-functional teams and with scientific communication points from the scientific communication platform.
• Interface and effectively collaborate with external stakeholders and internal cross-functional teams including: US commercial team, US medical affairs teams, clinical research, clinical operations and regulatory to ensure accurate and timely completion/delivery of scientific material.
• Represent medical affairs in relevant cross-functional teams and task forces. Develop and deliver presentations to colleagues and senior management as needed.
• Lead and execute all activities related to the preparation of scientific medical publications (i.e., medical, scientific, and health economics manuscripts, abstracts, posters, and oral presentations).
• Lead the development of the publication plan in conjunction with the cross-functional project teams based on clinical development milestones, availability of non-clinical data. HEOR project deliverables, product life cycle, and scientific and unmet medical needs and gain endorsement of the plan by key internal stakeholders prior to plan execution.
• Lead the timely execution of the publication plan, including vendor management.
• Ensure that scientific publication activities are within industry-standard guidelines for authorship and good publication practices (e.g. GPPE, ISMPP).
• Interface and effectively collaborate with external stakeholders and internal cross-functional teams including: clinical research, clinical operations regulatory, safety, biostatistics, to ensure accurate and timely completion/delivery of scientific publications.

Qualifications

• Advanced degree, (MD, PhD, or PharmD) with minimum 7+ years relevant medical communications experience within bio-pharmaceutical industry required.
• Experience in launch planning and launch related medical/medical communications tactics.
• Deep understanding of the strategic role that medical communications serves to support AveXis education and communication priorities and requirements.
• Proven strategic thinking and the ability to assimilate and interpret scientific content and translate information for appropriate audience.
• Knowledgeable of US and international regulations, requirements, and guidance associated with scientific publications, including GPPE, ICMJE recommendations, and the development and documentation of compliant material with understanding of Datavision.
• Ability to work on several projects at once while balancing multiple and overlapping timelines.
• Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight.
• Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.

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.