Director, Risk and Resilience

Location
Deerfield, IL, US
Posted
Sep 04, 2020
Ref
5336
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
Overview

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.

AveXis seeks a compliance professional to lead the Company's compliance programs and provide day-to-day support to cross-functional teams on various compliance matters, with a focus on transparency reporting, FDA promotional matters, charitable spending, training/policy management, and privacy, including alignment to parent company policies.

The Director will provide strategic and operational support in the implementation and continuous improvement of the global AveXis Ethics Risk & Compliance (ERC) Operations and Risk & Resilience programs. In close collaboration with global management and the ERC team, (s)he will identify opportunities to proactively address existing and emerging risks. This role will also lead the development and execution of effective assurance activities and remediation efforts across AveXis.

Responsibilities
  • Lead the Enterprise Risk Coordination process across AveXis, enabling an efficient execution of risk management activities by coordinating and organizing related activities of preparation, communication, execution and follow-up.
  • Support implementation of end-to-end AveXis ERC assurance activities, including but not limited to a risk assessment and monitoring program (RAM).
  • Provide input into the ERC Monitoring strategy, including but not limited to further development of P3 Control Framework and RAM system enhancements.
  • Develop ERC management reports considering internal and external metrics, to provide insights into AveXis ERC performance, including identification of new/emerging risk areas and related risk reduction measures.
  • Lead implementation of the Business Continuity Management (BCM) framework and & NEM standards.
  • Consolidate BCM risk portfolio for AveXis ensuring adequate BCM & NEM planning is established for top risks with high impact.
  • Support appropriate ERC training/ awareness.

Qualifications
  • Bachelor's Degree required (life sciences, public policy, marketing, business, or related discipline preferred).
  • Advanced degree desirable (PharmD, PhD, MS, MPH, MBA or similar degree in life sciences, public policy, regulatory, or related discipline, with more than one degree preferred).
  • Knowledge of and experience in the healthcare legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry.
  • Minimum of 10 years of healthcare industry experience or related experience working in a regulated function (R&D, med affairs or commercial team) in a large matrixed organization.
  • Direct experience with pharma/biotech regulations governing clinical, research or commercial activities, in either a healthcare provider or manufacturer setting, such as operating under a Corporate Integrity Agreement.
  • Ability to work independently to solve problems and recommend solutions; but also collaboratively as part of a cross-functional team.
  • Demonstrated ability to consult or advise internal stakeholders, build strong relationships, and balance potentially conflicting goals.
  • Excellent interpersonal and communication skills including oral and written communication and presentation skills.
  • Demonstrated ability to proactively identify and focus on critical compliance issues and manage several projects simultaneously.
  • Strong leadership skills with ability to build trust and confidence with a wide range of stakeholders.
  • Deep project management expertise, including setting up tracking/monitoring systems, knowledge management, database/document organization, risk maps, and presentations.
  • Ability to travel up to 3-4 times per year.
  • Strong preference for an individual with institutional knowledge of Novartis compliance policies and practices.


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.