Project Manager, Clinical Development

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Mar 25, 2019
Ref
2019-2920
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 Project Manager for Clinical Development to be responsible for supporting the team in developing, maintaining, tracking and reporting timelines for clinical development deliverables. This role will also support strategic activities for Clinical Development and the development of the overall Clinical Development Strategic Plan, reporting on progress for agreed clinical development goals for the portfolio of AveXis clinical development projects across the full development lifecycle (first in human to phase 3B).

Responsibilities

  • Support all Clinical Development planning and activities including creation of Clinical Development Plans and adaptations, timelines and resources.
  • Coordinate project resourcing for the Clinical Development organization serving as a contact to clinical operations, regulatory, commercial organizations at the department level.
  • Support preparation of clinical development timelines, schedules, resources, and budgets.
  • Monitors ongoing resource needs for clinical development and makes recommendations to adapt plans and resources where necessary, in conjunction with head of Clinical Development.
  • Attends regular meetings with Head of Clinical Development, Medical Directors and others for assigned projects.
  • Prepares weekly and/or monthly project status reports for Clinical Development projects, discussing project status with Head of Clinical Development and taking necessary actions.
  • Track Clinical Development key goals and incorporate progress into periodic reports.
  • Key interfaces: (1) Project managers across CMO function and CMO Portfolio Strategy & Operations Head; (2) Clinical development partners; (3) Clinical Development Medical Directors, Head of Medical Writing, Head of Statistics.
  • Management of the Development Staff meetings, medical writing outsourcing meetings, and other meetings as needed.
  • Provide support for clinical development communications, including slide presentations and clinical development messaging.


Qualifications

  • Bachelor's degree in a scientific discipline; masters/PhD/PharmD preferred.
  • Minimum of 5-7 years of experience (7+ with Bachelor's) in Global Drug Development with focus on the clinical function and clinical project management spanning Phase 1 to 3B.
  • In-depth understanding of pharmaceutical clinical development plans and regulatory requirements and their impact on the development of clinical trials and BLAs/MAAs.
  • Able to write clearly and succinctly in a variety of communication settings; open, transparent and excellent communication skills, both verbal and written.
  • Experience in developing and managing clinical trials, including vendor management.
  • Demonstration of being proactive, engaged in problem solving, creative, and preferably a strategic ability beyond simple project management.
  • Demonstrated organizational and collaboration skills.
  • Ability to deliver professional and quality work products while working on multiple projects.
  • Proficient in use of Microsoft Office and project management software systems.
  • Desire and ability to work in a fast-paced, dynamic environment.


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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