Director, Global Medical Information

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 07, 2018
Ref
2018-2463
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 of Global Medical Information reports to the Executive Director of Global Medical Information, and oversees the provision of technical and medical information with high quality customer service, researches and prepares responses for escalated medical inquiries as well as Customized Response Documents related to multiple or assigned therapeutic areas.

The Director, Global Medical Information is responsible for serving as the scientific, clinical and therapeutic area expert and provides medical and scientific support for all AveXis investigational and marketed products, new indications for marketed products and compounds in development. The role is responsible for the execution of Medical Information deliverables in collaboration with the Executive Director, Global Medical Information.

Responsibilities

  • Develops, updates and reviews relevant, unbiased medical information response documents and product profiles that are provided to customers and ensures content represents the most current, complete, medically accurate, evidence-based and scientifically balanced information.
  • Utilizes the appropriate information resources to identify published literature and respond to medical information inquiries from healthcare professionals, consumers, and internal business partners verbally and/or in writing; prepares customized responses as needed.
  • Proactively develop and/or create medical response documents as well as revise and/or update existing documents in the database.
  • Conduct literature searches and critically evaluate results to respond to escalated external inquiries as well as internal business partner inquiries.
  • Respond to field personnel or other internal and external customers on medical information requests in a timely manner.
  • Critically evaluate published medical and scientific literature on AveXis products and competitive products; review internal/external literature to stay abreast of med/market trends and provide the appropriate training to AveXis colleagues.
  • Leads the development of Medical Information content (e.g., SRLs, FAQs and Literature searches, Medical Content and Promotional Content reviews), and ensures that content allows for scientific exchange (non-promotional, truthful, fair and balanced).
  • Proficiently communicate information gathered and researched from various sources to appropriate internal functions and roles.
  • Contributes to MI planning and preparation activities for new product launches, line extensions, and key data releases.
  • Collaborate effectively and proactively with Medical Affairs, HEOR, publications and clinical development groups to maintain a robust and current product knowledge repository and accurate medical communications.
  • Collaborates with Regulatory and Legal/Compliance officers to manage language and dissemination of materials for internal and external stakeholders.
  • Serve as liaison between Medical Information vendors and internal business partners including Quality and Global Patient Safety (GPS) to oversee AE/PC intake and reconciliation.
  • Collaborates with GPS and product supply to ensure timely processing of potential safety and product complaint issues.
  • Ensures compliance with corporate policies and procedures, as well as US healthcare laws and regulations.
  • Communicate information gathered and researched from various sources to appropriate internal functions and roles.
  • Maintain open communication to ensure work across matrix organization.
  • Conduct on-going training to AveXis personnel and speakers as needed.


Qualifications

  • Advanced scientific degree (MD, PharmD, PhD), with 5 - 8 years medical information experience required in pharmaceutical industry.
  • Must possess an in-depth understanding of human physiology/pharmacology and integrative organ systems.
  • Thorough knowledge of drug development, registration and marketing process.
  • Advanced computer skills necessary.
  • Excellent organizational skills; excellent attention to detail.
  • Proven successful experience working in a high-paced, multidisciplinary, pharmaceutical environment.
  • Excellent oral/written communication and presentation skills.
  • Strong collaboration and interpersonal skills.
  • Project and process management skills.
  • Able to work independently as well as on a team.
  • Experience working across matrix organization / cross-functionally.
  • Occasional travel (up to 30%) for conferences and meetings.
  • 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.
  • Performs other duties as assigned.


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.