The Principal Scientist within the Nonclinical Development department at Precision BioSciences will report to the VP, Nonclinical Development. The Principal Scientist has extensive pharma/biotech experience in preclinical and translational sciences to support the advancement of Precision's gene editing and cell therapy pipeline. The Principal Scientist will collaborate with external contract research organizations (CRO's), academic collaborators, and internal functions to design and execute experiments to elucidate efficacy, biomarkers of efficacy, tolerability, and potential toxicity of gene editing or cell therapy drug candidates. This individual will work independently within project teams and design studies, protocols, review data and reports, author reports, and contribute to nonclinical sections of regulatory documents and scientific manuscripts. The Principal Scientist will establish pharmacodynamic/efficacy relationships in predictive disease models and identify/evaluate biomarkers of efficacy and toxicity in a nonclinical setting and will conduct GLP studies to support regulatory filings and safety monitoring in the clinic.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
- As a subject matter expert, contributes to the design, execution and interpretation of nonclinical safety according to relevant regulatory requirements including review of literature and assessment of compliance
- Manage nonclinical projects as assigned, including coordination of laboratory and Precision Biosciences activities
- Develop relationships with external vendors and academic collaborators to serve as Study Monitor/Sponsor Representative for pharmacology/biodistribution/toxicity studies
- Act as study monitor when conducting GLP studies in both small (e.g., rats, mice) and large animals (e.g., nonhuman primates, canines)
- Travel to and scientifically qualify these vendors and conduct fit-for-purpose proof-of-concept and pilot animal studies
- Identify and/or develop translational biomarkers for both efficacy and toxicity readouts using in vivo models
- Provide oversight and expertise in evaluation of preclinical in vivo models relevant to specific gene therapy targets
- Serve as Translational Science and Nonclinical program representative on a multidisciplinary team of research and development scientists to progress candidates from lead optimization through NDA/BLA-enabling studies
- Support the authoring and/or review of document required for regulatory interactions and filings, regulatory compliance, and filings in support of applications for first in human studies through the provision of data and preparing reports and appropriate sections of regulatory documents as well as contribute to preparation and review of manuscripts for journal submission
- Ability to contribute nonclinical expertise and gain deep understanding of specific rare diseases across target areas focused on liver, skeletal muscle, and central nervous system disorders
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
· Advanced degree, M.S., Ph.D., or DVM, in a related field (Toxicology, Immunology, Biology, Biochemistry, etc.) and 14+ years of relevant experience in the pharma/biotech industry, or equivalent combination of education and experience
- Experience with gene or cell therapies, with a thorough understanding of multiple gene editing delivery techniques, such as AAV or LNP delivery
- Experience in gene editing
· DABT certification or eligibility
- Ability to independently design experiments and analyze experimental data and present results in both nonclinical and cross-functional team settings
- Significant understanding of the role of translational research and biomarkers in relationship to efficacy and toxicity in drug development
- Experience in predictive and exploratory biomarker identification and translation from nonclinical models to a clinical setting in diverse disease areas
- Hands-on experience in development of in vivo models and design and conduct of in vivo studies for evaluation of efficacy and/or toxicity
- Excellent communication skills with ability to thrive in matrixed, cross functional teams
- Experience with outsourcing of studies at CROs and oversight of study design, budget, and program-timing
- Experience in study directing and/or study monitoring of in vivo studies, including NHP studies
- Creation of datasets and reports for regulatory filings
· Will be expected to travel (primarily domestic) potentially up to 1x/month.
· This is an office-based position located at the main headquarters in Durham, NC. This role will be able to function remotely in accordance with company guidelines but is subject to change as needed.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.