Associate Director, Medical Information

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 Associate Director, Medical Information reports to the Director, Global Medical Information and is responsible for all functions of Medical Information, including standard content creation, responding to unsolicited inquiries from healthcare providers and patients, medical and promotional material review process, and literature services.

Responsibilities

• Leads the development of Medical Information content (e.g. SRLs, FAQs and Literature Searches). Ensures that content allows for scientific exchange (non-promotional, truthful, and fair and balanced).
• Develops and communicates appropriate, quality, and timely responses to Medical Information requests from healthcare providers and patients.
• Collaborates with field medical and field commercial leads to ensure efficient process for receiving and responding to medical inquiries from Field Based Commercial and Field Based Medical Teams.
• Provides medical review of promotional and medical materials according to the PRC and MRC review processes.
• In collaboration with Therapeutic Medical Director and subject matter experts, develops and communicates timely, accurate responses to unique and escalated inquiries.
• Collaborates with Pharmacovigilance and Quality to ensure timely processing of potential safety and product compliant issues, reconciliation of Med Info cases containing AE and/or PC information, and regular training of Med Info colleagues.
• Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations

Qualifications

• Advanced degree (PhD or PharmD) required.
• 4 - 8 years' experience in medical information; or 6-10 years equivalent experience; Neurology experience preferred.
• Proven track record of successful medical information in prior biopharmaceutical companies; ideally in a small company environment; can easily point to examples including applying IT solutions, fulfill medical information requests and manage medical information capabilities.
• Established network of medical information call center vendors.
• Occasional travel (up to 30%) for conferences and meetings.
• Successful experience in fast-paced entrepreneurial environment.
• Fit with AveXis culture and values.
• Strives to maintain a safe working environment through the prevention of accidents, the preservation of equipment, and the achievement of safe working practices.
• Maintains a positive and professional demeanor toward all customers and coworkers.
• Adheres to all policies and procedures of AveXis.

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.