Senior Manager, Program Management Regulatory Submission

Job Locations US-IL-Bannockburn
Posted Date 1 month ago(2/20/2018 3:31 PM)
Job ID
# of Openings
Program Management


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.


  • Assume oversight of internal Program Management for Regulatory Affairs and Regulatory Submissions
  • Collaborate with Team members to establish effective, productive relationships with key internal individuals, including but not limited to the clinical and manufacturing organizations.
  • Work closely with the Head of Corporate Operations and Senior Director of Program Management to develop, drive, operationalize, and execute the program strategy.
  • In partnership with the Senior Director of Program Management, ensure timely and substantive updates on Program Management Team progress.
  • Partner closely with the Regulatory organization to shape the Program strategy, goals and plans to ensure close alignment within the Regulatory organization.
  • Facilitate the SMA Submissions team and drive the global cross functional group to a successful regulatory submission
  • Build detailed project plans based on the development plan to assist in successfully completing project objectives and goals for SMA studies.
  • Support and/or manage resources that support the Program Management Team.
  • Serve as a key liaison for Program Team Members, particularly on issue identification, resolution and escalation.
  • Ensure various programs remain on track; own the timelines without any deviation.
  • Drive Team effectiveness by setting and communicating clear expectations on deliverables, roles and responsibilities, and by promoting Team cohesiveness.
  • Proactive identify potential issues and work to remove barriers; escalate issues appropriately that cannot be resolved by the Team.


  • An undergraduate degree in an area related to life sciences. A graduate degree such as a PhD, PharmD, or MBA is highly desired; a PMP designation is preferred.
  • A minimum of 10+ years of experience with drug development and operating in a biotechnology/pharmaceutical industry, preferably in a company focused on orphan or rare disease drugs.
  • 7-10 years of experience in the Program/Project Management of complex cross-functional biotechnology/pharmaceutical product development projects with aggressive milestones in the regulatory environment.
  • Demonstrated ability and cross-functional experience and management of integrated teams and programs from a Life Sciences point of view.
  • Deep experience and strong understanding of the nuances of Regulatory, and managing cross-functional teams and R&D Life Sciences Programs.
  • Exposure to the success and failure of drug candidates; ability to be creative and think outside of the box regarding the path to commercialization.
  • An innovative thinker, with a track record for translating strategic thinking into action plans and output.
  • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
  • Stature, gravitas, and confidence to gain the credibility and respect of peers.
  • Self-reliant, a good problem solver and results-oriented, and comfortable working in a fast-paced environment.
  • An excellent and persuasive communicator.
  • Energetic, flexible, collaborative and proactive; a team leader who can positively and productively impact initiatives.

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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