Exton, PA (Corporate)
Scope: The Preclinical group at Frontage Laboratories is seeking a highly-motivated veterinary pathologist to join our team in Exton, PA. The candidate will be expected to provide scientific expertise and leadership by contributing to the safety assessment of potential therapeutic and chemical agents for various species. The candidate should possess an in-depth understanding of anatomic pathology, and have experience in designing and critically evaluating results of exploratory and GLP-compliant toxicology and safety studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities are required. This position will be part of the Preclinical team supporting multiple programs at all stages of development in various therapeutic areas.
Responsibilities: Diagnose and interpret compound-related effects in animals including assessment of cause of death, target organs of toxicity and reversibility of toxicity by providing expert primary pathology reads on exploratory and definitive toxicity studies. Serve as the Peer Reviewer Pathologist supporting GLP compliant toxicity studies performed for clients. Manage toxicology/pathology related program-specific plans and timelines.
Education / Experience: Experience performing pathology assessments in the pharmaceutical industry, or other GLP environment, and demonstrated in-depth understanding of the regulatory issues pertaining to pathologic data interpretation and presentation are required. DVM with Board certification in American College of Veterinary Pathology is required. 5+ years in preclinical safety assessment of novel therapeutic entities. Knowledge of GLP compliance and relevant ICH & FDA guidance documents. Outstanding interpersonal skills and verbal and written communication skills. Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment. Ability to work well with Sponsors and collaborators with professionalism and discretion. Ability to travel to monitor studies at our Ohio facility. Outstanding organizational skills/ability to prioritize and deliver in timely fashion