Senior Director, Medical Affairs Operations and Excellence

Employer
AveXis Inc.
Location
Bannockburn, IL, US
Posted
Sep 07, 2018
Ref
2018-2417
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
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. 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 Senior Director will work with the head of Global Medical Affairs (GMA), all centers of excellence within GMA and regional teams and their senior-level and executive management to ensure that some recently identified initiatives to strengthen the Global Medical Affairs organization, in preparation for launch, managing the lifecycle of AVXS-101 and to advance the scientific exchange regarding the pipeline and platform, are planned, executed, and socialized well. The current processes overall, operational rhythm, and optimal communication will be general themes to be addressed.

The Senior Director will act as owner of "Medical Excellence", be responsible for executing these initiatives, and measure and report impact, spanning this launch year, 2019 and several years beyond as new products leveraging the AveXis gene therapy platform. The most pressing of these processes is a global process in place to review grants, represent them fairly, and allocate funds in accordance to AveXis' strategic priorities. This individual will ensure integration of grant management and other data systems and associated processes across other AveXis departments and regions (e.g., EMEA) and help drive the strategic direction along with other functional partners and execute on the agreed-to strategy.

They will also own related processes as well as operations regarding all Managed Access Programs (Compassionate Use, Early Access, etc.). This position will also be working cross-functionally to streamline standard operating procedures (SOPs) across the corporation and incorporate requisite Medical considerations.

Responsibilities

  • Near and mid-term responsibilities will focus on strategic direction and development, requirements and scope management of senior and executive level stakeholders needs across the organization, implementation, and management, including the cross functional coordination and alignment with corporate strategic priorities related to:
  • Grants, IIT / CMEs
  • Managed Access Programs
  • Processes / SOPs
  • Overall systems management
  • Longer term responsibilities will drive Medical Excellence by working with and supporting Medical Office and Regional leaders as well as presenting to AveXis Leadership team on key strategic aspects, opportunities and risks of the above programs and any strategic and operational initiatives identified within GMA.
  • For the immediate needs around grants, IIT, and other evidence generation activities, works with compliance officer team to ensures compliance is integrated into day-to-day operations.
  • Provides clear and concise grants administration policies and procedures for internal stakeholders and grantees.
  • Coordinate the grant steering committee and participate in the strategic planning and review of grant applications.
  • Responsible for managing the process, all information, case management regarding Managed Access in a compliant manner.
  • Coordinate with finance to ensure the timely and thorough use of funds for purposes outlined by the funding source.
  • Create and maintain required reporting on the status of projects and the appropriation and use of funds.
  • Utilize or create key performance indicators (KPIs) as needed for initiatives led by candidate but also contribute to KPI creation for initiatives led by GMA functional leads.
  • Build and manage platforms, processes, and tools (e.g., SOPs) necessary to align internal stakeholders across all departments and serve as references for new joiners, in alignment with compliance requirements.
  • Ensure the development of SOPs governing Medical activities according to compliance needs; act as the centralized point of contact for SOPs creation and management.
  • Support other data system buildout (processes and system implementation) as needed.


Qualifications

  • BS, MS required.
  • Advanced degree (PharmD) desirable.
  • At least 5 years of experience that is directly related to grants management, IIT, and evidence generation activities.
  • At least 10 years of experience in the life sciences industry with a focus on Medical Affairs Operations.
  • Experience in working with Commercial preferred.
  • Demonstrated proficiency of grant funding policies and procedures.
  • Experience in Compassionate Use and / or Early Access Programs.
  • Proficiency in the drug development process (pre-clinical, to clinical, to commercialization).
  • Excellent written and oral communication skills, including strong formal presentation skills.
  • Excellent planning and organization skill.
  • Ability to monitor and apply regulatory agency regulations, guidelines and/or specifications related to rare disease programs.
  • Ability to initiate and lead large, cross-function projects and see it through to completion.
  • Ability to think and act decisively about program and operational issues or use experience-based good judgment on when to escalate risks, concerns, or decisions.
  • Ability to manage senior level and executive level stakeholders across related and dependent functions (e.g. Commercial and Medical0 through varying stages of project implementation required.
  • Detail oriented, well-organized, have knowledge of good documentation practices, and knowledge of scientific terms and (preferably) change request forms.
  • Willingness/Ability to travel at times is required.


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.