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 Senior Project Manager, Translational Medicine is responsible for supporting the team in developing, maintaining, tracking and reporting timelines for translational medicine deliverables.
- Support strategic activities for Translational Medicine and the development of the overall Translational Medicine Strategic Plan, reporting on progress for agreed Translational Medicine goals for the portfolio of AveXis translational medicine projects across the full development lifecycle (first in human to phase 3 clinical trials).
- Manage Translational Medicine planning activities including creation of Translational Medicine plans and adaptations, timelines and resources.
- Coordinate project resourcing for the Translational Medicine organization, serving as a contact to research, clinical development, clinical operations, regulatory, and commercial organizations at the department level. Manage Translational Medicine timelines, schedules, resources, and budgets.
- Monitors ongoing resource needs for Translational Medicine and makes recommendations to adapt plans and resources where necessary, in conjunction with head of Translational Medicine.
- Attends regular meetings with Head of Translational Medicine, Medical Directors, Directors, Translational Scientists, Managers, Administrative Coordinator and others for assigned projects.
- Prepares weekly and/or monthly project status reports for Translational Medicine projects, discussing project status with Head of Translational Medicine and taking necessary actions. Track Translational Medicine key goals and incorporate progress into periodic reports.
- Key interfaces: (1) Project managers across CMO function and CMO Portfolio Strategy & Operations Head; (2) Translational Medicine partners; (3) Translational Medicine team members (4) Head of Translational Medicine and Clinical Development.
- Provide support for Translational Medicine communications, including slide presentations and Translational Medicine development messaging.
- Management of the Translational Medicine Staff meetings, Scientific Exchange meetings, and other meetings as needed.
- Other related duties as assigned.
- Bachelor’s degree in a scientific discipline, Masters/PhD/PharmD preferred.
- 8 years’ of experience in Global Drug Development with focus on the clinical function and clinical project management spanning Phase 1 to 3.
- In-depth understanding of pharmaceutical translational medicine and 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.
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.