Manager, Clinical Trial Monitoring

Employer
AveXis Inc.
Location
Bannockburn | US-Remote, IL, US
Posted
Mar 11, 2019
Ref
2019-2879
Hotbed
BioMidwest
Required Education
Bachelors Degree
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 (ZOLGENSMA®). 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 Manager, Clinical Trial Monitoring, who will manage a team of CRAs within the assigned region in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within defined budgeting.

Responsibilities

  • Functional Management and Staff Development
    • Direct supervision of assigned staff, including training, development, hiring, and the full spectrum of performance management
    • Accountable for the quality of performance of his/her direct reports
    • Responsible for the coaching, development, and growth leading directly to improvement of talent within the assigned region to meet increasing levels of responsibility
    • Ensures that standardized goals and objectives are implemented on a functional level in support of corporate and department goals
    • Supports the implementation and execution of strategies employed by Clinical Operations staff to meet corporate goals or directives
    • Ensures proactive management of staff and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Director/Department Head in Clinical Operations
    • May establish, analyze and review appropriate metrics to ensure staff are compliant with goals and objectives
    • May support the identification of training needs within function and the development of training materials to meet those needs. May provide mentoring or training as required to improve core competency and skill set of the function or region
    • May participate and implement continuous improvement processes for function or organization
  • Departmental Management:
    • Ensures compliance with the application and communication of all AveXis policies, procedures and fundamentals within the assigned region
    • Ensures that all direct reports understand and work toward corporate, department, and individual goals and that the measures of those goals are understood and accepted
    • Active membership on departmental management teams
    • Budget and Contract Coordination: ensures operating budget is managed in line with organizational expectations, including expense management.
  • Project Support:
    • Ensuring harmonization of field and in-house monitoring practices
    • May provide back-up coverage for CRA outages / PTO
    • May perform CRA mentoring, training, metrics analysis, and trip report review
    • May participate in continuous improvement initiatives for function or department


Qualifications

  • A minimum of 1 year on-site monitoring experience.
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • Bachelor's degree, preferably in a life science; Master's degree preferred.
  • Approximately 50% overnight travel for meetings, oversight visits.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills as demonstrated at a management level.
  • Demonstrated computer skills (MS Office, MS PowerPoint, EDC, CTMS, IRWS and eTMF preferred).
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
  • Knowledge of GCP as it relates to clinical trial management.
  • Strong written and verbal communication skills; learn quickly; handle multiple studies and aggressive timelines.


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.