Director, Program Management, Global Patient Safety
- Employer
- Novartis Gene Therapies
- Location
- Bannockburn, IL, US
- Start date
- May 22, 2019
View more
- Discipline
- Administration, Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- BioMidwest
You need to sign in or create an account to save a job.
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.
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
Qualifications
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.
#LI-EC1
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.
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.
#LI-EC1
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert