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Director, Clinical Operations Physical Medicine and Outcomes

Employer
Novartis Gene Therapies
Location
Bannockburn, IL, US
Start date
Sep 14, 2019

View more

Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioMidwest
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 is seeking a Director, Physical Medicine and Outcomes (PMO) to provide strategic leadership and mentorship on the development and implementation of clinical outcomes assessments in clinical studies. The Director PMO will serve as the PMO expert for assigned clinical programs and requires collaborating with cross functional teams to develop a PMO strategy across the life cycle of a product. The Director will consult on the appropriate use, analysis, and interpretation of PMOs within each clinical program. Must be able to work at a fast pace and manage multiple complex projects and priorities.

Responsibilities

  • Key contributor and influencer of protocol development including endpoint selection related to clinical outcome assessments.
  • Identify and oversee execution of operational needs necessary to drive clinical outcome assessments in clinical studies.
  • Identify, select, oversee management of third-party vendor selection (e.g. organization or consultant-based work) including any systems required for vendors involved in processing information related to clinical outcome assessments (e.g. patient developmental milestones).
  • Direct and oversee the development of training material, reliability testing, etc. related to clinical outcome assessments.
  • Supports the implementation and execution of clinical study strategies employed by Clinical Operations staff to meet corporate goals or directives.
  • Provide strategic input to the development of global systems, standard operating procedures, and templates for PMO function within Clinical Operations.
  • Direct continuous improvement initiatives and facilitate cross functional process improvement teams.
  • Active member of Clinical Operations leadership team.
  • Contribute to budget forecast and estimates for the PMO function within the Clinical Operations department; oversee and manage performance of budget.
  • Ensure compliance with all applicable laws, regulations and regulatory guidelines governing Physical Medicine and Outcomes functional management.
  • Proactively and positively coach, develop and engage Clinical Operations team members and PMO direct reports.
  • Ensures that standardized goals and objectives are implemented on a functional level in support of corporate and department goals for AveXis personnel.
  • Responsible direct report performance and growth leading directly to the improvement of capabilities of PMO staff.
  • Provide strategic input to PMO operations including resource identification, organizational structure.


Qualifications

  • Master's or Doctorate degree in life science.
  • A minimum of 7 years of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or healthcare setting.
  • Strong experience in managing multiple projects across a variety of patient outcomes methodologies and therapeutic areas.
  • Must have experience related to Patient Outcomes in clinical trials.
  • Ability to successfully manage and develop a remote-based team.
  • Demonstrated effective planning and project management skills.
  • Analytical, negotiation, meeting management, cross-functional team and leadership skills as demonstrated at a management level.
  • Demonstrated computer skills (MS Office, EDC, CTMS and eTMF preferred).
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
  • Demonstrates core understanding of ICH GCP, EU Directive, FDA Regulations, and other local regulations/legislation.
  • Excellent understanding and ability to adapt to multi-cultural/multi-national environment.
  • Excellent analytical, written, and verbal communication skills as well as presentation skills.
  • Ability to travel globally


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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