Pre-Clinical Study Monitor and Principal Investigator- Gene Therapy

Location
San Diego, CA, US
Posted
Nov 05, 2020
Ref
5778
Hotbed
Biotech Beach
Required Education
Associate Degree
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.

The Pre-Clinical Study Monitor and Principal Investigator, is responsible for coordinating scientific activities of contracted preclinical platform-enabling or tolerability non-rodent studies for AAV gene therapies, including direct interactions with groups in GTx Research and Early Development, NIBR Preclinical Safety (PCS) and PK Sciences, Project Team Members, Animal Care and Use Committee, Quality, and ESP personnel.

Responsibilities
  • Ensures proper design, initiation, and reporting of contracted non-GLP, non-rodent platform-enabling (pharmacology, biodistribution, PK/PD) and tolerability/dose-range finding toxicology studies for AAV gene therapies conducted at External Service Providers (ESPs).
  • May serve as Investigator for collaborative internal non-GLP rodent pharmacology and AAV platform-enabling studies.
  • Works collaboratively with subject matter experts and technical associates in GTx and Novartis Institutes of BioMedical Research (NIBR) on study design, data evaluation and integration, and reporting.
  • Ensures contracted studies are compliant with Novartis animal welfare policies, ESP in-house standard operating procedures, Novartis expert recommendations (when feasible), and all relevant international regulatory guidelines/regulations as appropriate for study type and objectives.
  • Ensures assigned studies are compliant with all internal procedures, working practices, animal welfare, OSHA regulations, and company policies.
  • Preparation of internal in vivo pharmacology and AAV platform study protocols, overseeing study conduct, report writing, coordination of cross-functional study contributions, and review and finalization of study report.
  • Advances the concepts and practice of Good Research Practices and a quality culture within GTx Research.
  • Develops and maintains expertise in AAV gene therapy through journal reading and attendance at internal and external scientific meetings and applies expertise to preclinical study design for gene therapies.
  • Other related duties as assigned.

Qualifications
  • Bachelor's degree in relevant Life Sciences (or equivalent) with 10 years experience in preclinical study lead/directing and/or monitoring, or Master's or PHD degree in relevant Life Sciences with 5 years' relevant experience in preclinical study lead/directing and/or monitoring.
  • Effective organizational and prioritization skills with ability to work cooperatively in a team environment under specific timelines.
  • Excellent verbal and written communication skills.
  • Good knowledge of preclinical laboratory methodologies (pharmacology models, biodistribution, formulations, in vivo dosing and observations, clinical pathology/biomarkers, pathology).
  • Good understanding of animal physiology and laboratory animal welfare standards (USDA, AALAC, etc...).
  • Strong computer skills including Microsoft 360; familiarity with data entry/auditing systems and document management systems a plus.


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-JH1