Director, Medical Publications

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a Director of Publications who will be responsible for leading a publications team and driving publication strategy to disseminate key scientific data. The successful candidate will play a major role in establishing AveXis' scientific leadership with credible and timely publication of pre-clinical, clinical, and HEOR-related data to key audiences in the extended scientific and medical community.

Responsibilities

• Lead the development and execution of an actionable global publication plan to meet Medical Affairs strategy and objectives.
• Ensure broad cross-functional alignment by leading an all-inclusive annual publication planning meeting to address and revisit unmet needs, gaps, SWOT, and assessment of the scientific and competitive landscape.
• Ensure continued alignment with monthly cross-functional meetings.
• Oversight of update and execution of the strategic and tactical publication plan in alignment with the project teams based on clinical development milestones, HEOR project deliverables, product life cycle, and unmet scientific and medical needs.
• Develop publication key performance indicators and generate analytic reports related to publication projects.
• Demonstrate disease state expertise and knowledge of current medical and/or regulatory issues related to company products. Provide scientific/clinical direction and guidance on matters related to publication planning and data disclosure.
• Oversee and track the overall publication budget and resource utilization, monthly reporting, forecasts and budget plans. Collaborate with Procurement for periodical vendor business reviews and RFP assessments.
• Manage vendors to ensure high quality, on-time and within budget delivery of all publications related tactics.
• Foster collaborative relationships with academic and clinical experts, publishers, medical associations and other relevant external and internal cross-functional teams including clinical research, clinical operations, regulatory, safety and biostatistics, to ensure accurate and timely completion/delivery of scientific publications.
• Responsible for the development, maintenance, rollout and adherence to corporate policies, SOPs, and work procedures related to publication practices. Provide expertise on publication-related best practices and industry trends to optimize adoption.
• Ensure that scientific publication activities are within industry-standard guidelines for authorship and good publication practices (e.g. GPP, ISMPP).
• Provide strong departmental leadership to empower, motivate, mentor, and act as a role model to the Publication Team.

Qualifications

• Advanced degree (MD, PhD, or PharmD) with minimum of 8 years within bio-pharmaceutical industry required.
• Member of a relevant professional society (ISMPP, TIPPA, MAPS); CMPP certification is a plus.
• Experience with Datavision.
• Ability to interpret and synthesize complex clinical/scientific findings, statistical reports, translate findings and adapt messages for diverse audiences.
• Expertise with relevant publication related recommendations and guidelines (e.g. ICMJE, GPP3, HIPAA, GRDP, Sunshine Act, etc.).
• Global pre- and post-product launch experience.
• Knowledgeable of US and international regulations, requirements, and guidance associated with scientific publications, including GPP and ICMJE recommendations.
• Successful track record of managing a publication team 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.
• Travel (approximately 20%) will be required to represent company at conferences, presentations, and other meetings.
• 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.

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