Senior Program Manager, Therapeutic Lead
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. 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 Senior Program Manager, Therapeutic Lead to oversee and manage clinical research and act as a key contributor to develop studies and create standards and guidelines for clinical research services and programs. This position will manage projects ensuring adherence to standards operation procedures, good clinical practice/ICCH, and FDA-EMA regulations.
- Develop global operational strategies and ensure implementation of these strategies across assigned development programs.
- Assist in development of departmental Standard Operating Procedures, guidance, templates, and forms while ensuring adherence to good clinical practice/ICH and FDA regulations.
- Ensures effective oversight and performance of clinical activities related to multiple development projects in one therapeutic area.
- Provides clinical operational leadership in the design, execution and reporting of Phase I - III studies.
- Collaborates with KOLs, medical affairs, marketing and other key stakeholders as appropriate.
- Provides timely and accurate updates to Vice President, Clinical Operations during project reviews to contribute to optimal planning of resources, strategic and scientific application of expertise and effective functional support for assigned programs.
- Ensures successful management of global department vendors; work effectively with study teams, outsourcing and other functions to ensure consistency and quality in vendor processes and execution across studies within the program.
- Ensures globally integrated and optimal quality at the level of investigative sites, data and deliverables in collaboration with other team members and functions.
- Develops in-depth understanding of assigned therapeutic areas and facilitates transfer of knowledge to ensure operational excellence across program.
- Management of project staff.
- Responsible for the overall management and oversight of the development program for a product in a therapeutic area.
- Bachelor's degree required; Masters preferred.
- Minimum of 5 years clinical research trial project management experience.
- Pediatric, CNS or Oncology experience highly
- Experience with CTMS and data systems (i.e., IMPACT, Medidata RAVE, GRANTS MGR).
- CRO experience highly
- Proven analytical, verbal, and written presentation skills with a working knowledge of Microsoft Office applications including Word, Excel, Access, PowerPoint, and
- Demonstrated ability 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.