Medical Director

US-IL-Bannockburn
1 month ago
Job ID
2017-1039
# of Openings
1
Category
R & D

Overview

Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

 

AveXis develops gene therapies for rare neurologic disorders. The Medical Director will be responsible for design, conduct, execution and reporting of clinical studies in rare neurologic conditions, such as spinal muscular atrophy, Rett syndrome, and ALS. The Medical Director will need to work collaboratively with line management and other functional lines to develop coordinated and aligned clinical plans. The Medical Director will contribute to global regulatory submissions, providing written and verbal clinical, clinical development and scientific input. The Medical Director will serve as an interface with regulatory, clinical operations, manufacturing, commercial, and medical affairs groups to appropriately communicate information and assure coordinated delivery on goals.

Responsibilities

  • Provides oversight and management of clinical studies including planning, execution, completion and reporting of clinical trials according to all applicable regulations and guidance, ICH/GCP, and SOPs.
  • Partner with Clinical Operations to ensure all clinical study activities are completed efficiently and on time in accordance with applicable regulations and guidance.
  • Review clinical data from all phases of development and assist in generating study reports, publications and regulatory documents.
  • Coordinate, and provide ongoing assessment, evaluation, and communication with other departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.
  • Serve as study medical monitor, as needed
  • Identify and manage external collaborators, investigators, key clinical academic experts and consultants
  • Provide management personnel with timely updates on progress and proposed changes in scope, schedule, and resources as required.
  • Develop and implement SOPs for clinical trials and related activities, as required
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
  • Develop and maintain professional relationships with academic and community-based study sites
  • Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Commercial, Legal Affairs and Medical Affairs
  • Acquire and share publicly available knowledge of competitor products and clinical plans.
  • Incorporate Health Economics Outcomes Research requirements into protocol design.

Qualifications

Required:

  • Medical Degree (MD) with added qualifications in Neurology or Pediatrics and a strong scientific background 
  • At least 1 year of relevant experience in drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research (NCI, NIH, Academic Research groups etc.)
  • Demonstrable working-knowledge of regulatory procedures and guidelines in the US.
  • Proven track record in clinical study design, monitoring and execution and results analysis
  • Has demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
  • Proven record of working on teams and in a matrix environment.

Preferred:

  • Additional postdoctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
  • Prior experience in EU/US regulatory filing.
  • Experience in development of orphan drug products, neurology products, especially orphan neurology products.
  • Experience with Rett syndrome, spinal muscular atrophy, or ALS.
  • Demonstrable working-knowledge of regulatory procedures and guidelines in all geographic regions (global scope)

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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