Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
The Senior Manager, Program Management Regulator Submission will be responsible for assuming oversight of AveXis’ internal Program Management for BLA and other regulatory submissions, which will drive the future for AveXis. This individual will also manage and facilitate the cross functional Global Program Teams and drive the timelines for the regulatory submissions. He/she will play a critical role in establishing AveXis’ Program Management for regulatory submissions process and tools, risk assessment, mitigation, and strategic planning, with regards to resources, cross-functional plans and timelines across all programs that have to be submitted within the US and external to the US. This will include ensuring that Clinical Development, Regulatory, Medical Affairs, and Manufacturing strategies are integrated and aligned to deliver on the target product profile. This role serves as the intermediary between these functions, and with the Executive Team, working through issues and ensuring that functional plans are harmonized and critical decisions are made in a timely manner.
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.