Internship, Clinical Operations

Location
Bannockburn, IL, US
Posted
Sep 16, 2020
Ref
5556
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? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

Clinical Development is the department within Novartis Gene Therapies that is responsible for the planning, execution, and oversight of studies conducted in humans (clinical studies). The purpose of these studies is to determine the safety and efficacy of new treatments for disease. The ultimate goal of evaluating new treatments for diseases is for potential approved by the Food and Drug Administration and other regulatory authorities OR to determine at an early time point that the new treatment is not effective or have unacceptable risks.

The Summer Intern will support one or more clinical scientists in the planning, execution, or oversight of clinical studies. Potential activities may include the development of new protocols for clinical studies, evaluate data from either completed or ongoing studies, provide additional scientific support to the clinical scientists, and/or provide scientific or clinical support to interactions with regulatory agencies such as the FDA. This may include the evaluation or analysis of safety or efficacy data from ongoing or completed clinical studies.

Responsibilities
  • Develop protocols, synopses, or amendments to clinical study protocols, as needed
  • Evaluate or analyze data from ongoing or completed studies in rare neurological diseases
  • Assist in the oversight of execution of planned or ongoing studies
  • Evaluate or analyze data from ongoing or completed studies in rare neurological diseases for determinations of safety or efficacy.
  • Provide scientific and clinical support to other departments and functions within Novartis Gene Therapies which may include partnering with the departments of statistics, regulatory affairs, clinical operations, or others, as needed.

Qualifications
  • Enrolled in a PhD program
  • Experience in either preclinical or clinical research
  • A basic understanding of the clinical development process
  • Strong scientific acumen and general understanding of statistical methods
  • Able to work independently on individual tasks assigned and within agreed timelines
  • Must possess excellent Word, Excel, Powerpoint, and interpersonal skills.
  • Must have the ability to build and maintain positive relationships with management and peers.


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.

Novartis Gene Therapies 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.

#LI-EC1