A renown, northeast research and development organization client is looking to add a Veterinary Pathologist (anatomical) to leverage their expertise and provide support for preclinical research studies of gene therapy efficacy and toxicology studies for IND submissions.
As the Veterinary Pathologist, you will partner with Research Study Directors to determine the tissue and sample collection plans, using expertise to provide advisement as needed. You will perform necropsy on a variety of animal models, including nonhuman primates, using advanced techniques for dissection and sample collection under both GLP and non-GLP conditions. You will provide direction to the pathology core on types of histology and staining required to address pathology questions and to complete study report. You will perform microscopy analysis on prepared tissue slides and author comprehensive pathology reports of microscopic, gross, and clinical pathology findings for preclinical research studies, regulated filings, and scientific publications.
Joining this organization offers pathology professionals the unique opportunity to take part and review a wide variety of both IND-enabling toxicology studies as well as R&D and efficacy programs.
Partner with research directors to design pathological plan necessary for gene therapy efficacy and toxicology studies. Provide expertise to multi-functional project teams as a preclinical representative.
Perform animal necropsy on multiple animal species under both GLP and non-GLP conditions, including but not limited to mice, rats, cat, dog, pigs, and nonhuman primates. Use advanced techniques for dissection and sample collection. Advise pathology core on types of histology and staining required to address pathology questions and to complete study report.
Perform microscopy analysis on prepared tissue slides and author comprehensive pathology reports of microscopic, gross, and clinical pathology findings for preclinical research studies, regulated filings, and scientific publications; aid in the preparation of regulatory documents and IND/BLA submissions; collaborate with researchers, preclinical and clinical scientists, toxicologists, and biostatisticians to support projects in the areas of orphan disease gene therapy drug development
Participate in regulatory agency discussions as necessary; including pre-pre-IND, pre-IND and IND discussions with FDA/CBER. Perform other regulatory duties as assigned.
Author and update non-GLP study protocols and GLP standard operating procedures for pathological studies, sample handling/preparation, and analysis.
Remain current in all areas of pathology, scientific literature, and methodologies related to gene therapy products.
REQUIREMENTS-
Doctor of Veterinary
Medicine Degree with Pathology residency required with 5 or more years of
relevant research experience required.
A specialty
certification from the American College of Veterinary Pathologists (DACVP)
strongly preferred.
Should have in-depth
knowledge and experience in designing pathological studies and executing rodent
and primate safety studies.
Hands-on expertise
executing preclinical pathological studies of research animals, including
nonhuman primates is a must.
Experience with
associated regulatory filings helpful, but not required.
Experience working in
a GLP regulated environment preferred.
Self-organizing,
self-directing, highly motivated individual with strong analytical skills a
must.
Must
have excellent communication skills (both verbal and written).