Director, Clinical Operations Process and eTMF Management

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Mar 17, 2019
Ref
2019-3044
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 seeing a Director, Clinical Operations Processes and Electronic Trial Master File (eTMF) Management to lead the development and maintenance of clinical operations processes and procedures and management of the eTMF in accordance with Good Clinical Practice (GCP), ICH guidelines, federal regulations, and within a defined budget. These responsibilities include, but are not limited to, identification and development of processes that meet industry standards and best practices, ensure ICH GCP, and any other regulatory obligations; periodic review and update of existing processes; collection, review, and incorporation (as appropriate) for ongoing comments on existing processes; management and staff oversight for the eTMF. This position will also participate in growth of the eTMF staff. Must be able to work at a fast pace and manage multiple complex projects.

Responsibilities

  • eTMF Functional Management and Staff Development
    • Provide strategic input to eTMF operations
    • Direct supervision of assigned staff
    • Accountable for the quality of eTMF staff performance
    • Ensures that standardized goals and objectives are implemented on a functional level in support of corporate and department goals for AveXis personnel
    • Ensure proactive management of staff and collaborate on functional issues to ensure risks and mitigation strategies are identified early and communicated effectively to the Sr. Director/Department Head in Clinical Operations
    • May establish, analyze and review appropriate metrics to ensure staff are compliant with goals and objectives
  • Support the implementation and execution of strategies employed by Clinical Operations staff to meet corporate goals or directives.
  • Provide strategic input to the development of global systems, processes, and templates for Clinical Operations.
  • Establish aggressive but credible timelines for delivery or update of processes.
  • Direct continuous improvement initiatives and facilitate cross functional process improvement teams.
  • Ensure alignment of Clinical Operations processes with other AveXis functions.
  • Develop and maintain effective collaborations with internal key stakeholders and functions within and outside of Clinical Operations.
  • Participate in the review of processes and procedures of functions outside Clinical Operations that have impact on Clinical Operations.
  • Responsible for the coaching, development and growth leading directly to the improvement of talents of AveXis personnel to meet increasing levels of responsibility.
  • Support identification of training needs within Clinical Operations and the development of training materials to meet those needs. May provide mentoring or training as required to improve core competency and skill set.
  • Active membership on departmental management teams.
  • Budget and Contract Coordination: ensures operating budget is managed in line with organizational expectations, including expense management.
  • Supports other projects as assigned and identifies and contributes to best practices and process improvements.


Qualifications

  • Bachelor's degree, preferably in a life science; Master's degree preferred.
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • A minimum of 4 year of TMF/eTMF experience.
  • Excellent regulatory knowledge including, but not limited to, Good Clinical Practices (GCPs), ethics requirements for protection of human subjects, set-up and maintenance of Trial Master Files.
  • Demonstrated effective planning and project management skills.
  • 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.
  • Demonstrates core understanding of ICH GCP, EU Directive, FDA Regulations, and other local regulations/legislation.
  • Excellent understanding of multi-cultural / multi-national environment.
  • Excellent analytical, written, and verbal communication skills as well as presentation skills with working knowledge of Microsoft Office applications including Word, Excel Power Point, Visio, MS Project.


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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