Director, Clinical Operations (Program Leads)

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Jan 18, 2019
Ref
2019-2911
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 Director, Clinical Operations (Program Leads) to provide operational and program level support for several clinical trials (Phases I-III) under the leadership of the Head of Clinical Operations. This position includes overseeing the operational execution of development programs across development programs. The Director, Program Leads, will be accountable to ensure adherence to standard operating procedures, good clinical practice/ICH, FDA-EMA/global regulations.

Responsibilities

  • Develop global operational strategies including outsource model, resource model and ensure implementation of these strategies across development programs.
  • Participate with group leadership in development of departmental Standard Operating Procedures, guidance, templates, and forms while ensuring adherence to good clinical practice/ICH and global regulations.
  • Management of Program Leads across multiple therapeutic areas and ensure consistency of practices and procedures implemented across development programs.
  • Direct supervision of assigned staff, including full scope of people management (e.g. training, development, hiring, performance management).
  • Accountable for the quality of performance of direct reports.
  • Responsible for the coaching, development, and growth leading directly to improvement of talents of AveXis personnel.
  • Ensure proactive management of staff and collaborate on functional issues to ensure that risks and mitigation strategies are identified early and communicated effectively to the Head of Clinical Operations.
  • Identify gaps, implementing process improvements, including generation of SOPs, WIs, tools, guidance documents, etc. to support the needs of direct reports/department.
  • Ensure that standardized goals and objectives are implemented on a functional level in support of corporate and department goals.
  • Support the implementation and execution of strategies employed by Clinical Operations staff to meet corporate goals or directives.
  • May establish, analyze and review appropriate metrics using CTMS or other method of tracking aggregate data to ensure staff are compliant with goals and objectives.
  • Ensure effective oversight and performance of clinical activities related to multiple complex development projects across multiple therapeutic areas.
  • Develop in-depth understanding of assigned therapeutic areas and facilitates transfer of knowledge to ensure operational excellence across program.
  • May be responsible for contributing to generation, review, approval of documents including project-specific documents, program-specific documents, documents generated in support of R&D obligations/requests from regulatory authorities/requests from departments within AveXis.
  • Provides timely and accurate updates to Head of Clinical Operations during project reviews and ensures optimal planning of resources, strategic and scientific application of expertise and effective functional support for assigned programs.
  • Ensures operating budget is managed in line with organizational expectations
  • Provide adequate support to assigned staff including backup coverage, fulfillment of tasks assigned to various team members in support of project/departmental objectives
  • Participate in process improvement initiatives as requested.


Qualifications

  • Bachelor's Degree required, Master's Degree preferred
  • 8+ years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • Experience supporting multiple clinical trials/development programs required
  • Experience supporting global clinical trials required
  • Line management experience required
  • Pediatric, CNS or Oncology experience highly preferred
  • Excellent organization skills
  • Excellent analytical, verbal, and written presentation skills with a working knowledge of Microsoft Office applications including Word, Excel, Access, PowerPoint, and
  • Able to work at a fast pace and manage multiple complex projects.


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.