Job Summary (Primary function)
This position is responsible for providing pathology leadership and support across Discovery Biology, including Toxicology, Pharmacology and Translational Sciences.
Essential Functions of the Job (Key responsibilities)
·Provide pathology support for studies across Discovery Biology, including guidance on study design, endpoints, sample collection and processing and evaluation to address study objectives.
·Collaborate with drug discovery and development scientists in the design and execution of efficacy, investigative pathology and mechanistic studies, including experimental animal models (e.g., disease models, genetic models).
·Provide evaluation of clinical samples (e.g., biopsies), when needed.
·Evaluation and reporting of clinical and anatomic pathology in support of drug discovery and development.
·Maintain expertise on current and emerging techniques and technologies in pathology, including digital imaging technology, computational analysis of digital images, confocal microscopy, and analysis of fluorescent and light images for both nucleic acid and protein probes.
·Serve as primary pathologist for non-GLP toxicology studies and provide peer review for GLP Toxicology Studies, as needed.
·Actively participate in the evaluation and implementation of new approach methodologies (NAMs), including complex in vitro models (CIVMs).
·Participate in working group, project, and strategy team meetings as needed.
·Participate in senior level scientific, strategic, and operational aspects of drug development within the pharmacology, toxicology, and early stage clinical drug development process.
·Demonstrate a thorough understanding of ADME, CMC and clinical functions and ability to communicate effectively across disciplines in order to facilitate understanding and rapid resolution of issues.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·D.V.M. and Ph.D.
·DACVP certification.
·Experience with animal disease models, transgenic animal models, morphometrics, and small and large molecules desirable.
·At least 5 years of related experience in the pharmaceutical industry or related function.
·Demonstrated written and verbal communication skills; organized and detail-oriented.
·Understanding of regulatory requirements for small and large molecules.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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