Director, Program Management, Global Patient Safety

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Aug 09, 2019
Ref
2019-3589
Hotbed
BioMidwest
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

The Director will be responsible for creating, directing and managing Global Patient Safety (GPS) day to day business and projects and will collaborate with functional heads within GPS and cross-functional teams to support the operational aspects of the pharmacovigilance (PV) department. The individual will be the GPS point of contact and liaison for cross-departmental projects and activities. The qualified candidate will have experience in business and project management and perform program management related to overall global patient safety (GPS) strategy across the portfolio including managing business partners, third party vendors, budget, meetings and other GPS initiatives.

Responsibilities

  • Provide strategic planning, implementation, and management of Drug Safety and Pharmacovigilance activities for AveXis.
  • Project management of all GPS projects including collaborative projects with Novartis, clinical safety data migration and other GPS initiatives.
  • Point of contact for GPS projects and tracking of deliverables (e.g. aggregate reports, risk management, SOPs).
  • Manage PV vendors and business partners.
  • Collaborate with PV quality and compliance team in establishing and monitoring key quality and compliance metrics.
  • Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices.
  • Project management of EU and other regional launch readiness.
  • Project management of Argus clinical safety data migrations to Novartis from CROs.
  • GPS point of contact for cross-departmental projects including CMO, Regulatory, Quality and regions.
  • Scheduling and management of departmental and cross-functional meetings (e.g. Data Safety Monitoring Board (DSMB), Executive safety review committee meetings).
  • GPS Budget management.
  • GPS Share point management/maintenance.
  • Collaborate with Safety quality and compliance team in the development and implementation of an inspection readiness strategy.
  • Contributes to, drafts and implements department SOPs and work instructions related to the PV activities.
  • Represents GPS as a leader on project teams, other departments, and committees as needed.


Qualifications

  • Training in relevant subject, life science degree, and/or Post-graduate specialization in project or business management (e.g. PMP, MBA).
  • Minimum 5-10 years' experience in the pharmaceutical industry, predominately in pharmaceuticals project or program management, having worked on both development and marketed products.
  • Experience in managing pharmacovigilance projects desired.
  • Demonstrated leadership in complex project management with business partners and experience in vendor management.
  • Experience working on a cross functional team and strong project and business management skills.
  • Credible knowledge of global regulations governing Pharmacovigilance in the pharmaceutical industry and Research & Development processes.
  • Strong organizational, planning, prioritizing and problem-solving skills.
  • Effective multi-tasking skills applied in different and complex assignments and ability to work effectively under pressure and under strict timelines.
  • Ability to work both independently and collaboratively and use own initiative.
  • Ability to communicate effectively both locally and globally, internally and externally.
  • Operational expertise in ARGUS preferred.
  • Proficient MS Office skills.
  • Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements.
  • Tolerance for ambiguity and ability to adapt quickly to a changing business environment.
  • Highly resilient, tenacious and resourceful.
  • Occasional travel (up to 20%) for business, meetings and professional development activities.
  • High attention to details.
  • Maintains a positive and professional demeanor toward all customers and coworkers.


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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