Study Monitor, Preclinical
*This job is located in the South Bay*
BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Preclinical Study Monitor to work for a leading Bay Area biotechnology company.
Preclinical Study Monitor
Perform preclinical development activities (pharmacology and toxicology) for IND-enablement of gene therapy products.
- Manage operational aspects and timeline of preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, toxicology, and biodistribution/shedding studies
- Monitor conduct of preclinical studies with CROs, both through site visits and regular conference calls. Follow-up on action items with CROs to ensure on-time delivery
- Establish study timelines and insure that all study related activities are being addressed
- Write and edit preclinical study protocols and reports
- Work closely with the members of Preclinical Development on therapeutic development strategies
- Work closely with CROs to ensure that all studies are performed in a high quality, timely, and scientific manner
- Maintain a current understanding of pharmacology and toxicology literature and methodology, as well as the scientific literature related to the specific drug development projects
- Bachelor’s degree in Biological Sciences, Toxicology, Pharmacology, or a related discipline
- 5 years drug development experience, with minimum 3 years working in industrial pharmaceutical pharmacology/toxicology/safety assessment
- Proven experience in coordination, organization, analysis, and documentation of preclinical studies
- Ability to synthesize, organize, and analyze diverse, multidisciplinary data sets using Excel/ GraphPad/ PowerPoint or similar software
- Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing
- The ability to work independently and to collaborate with a multi-disciplinary group in a goal- and team- oriented setting
- Availability to travel to CROs for study monitoring activities
- Proficiency with MS Office and common laboratory software (GraphPad Prism, etc.).
- Working knowledge of FDA/ ICH guidelines relevant to preclinical development is a plus