The veterinary pathologist will serve as a study toxicologist/pathologist on toxicology and pharmacology-related studies and will interact with scientists across several disciplines both within and outside Global Nonclinical Development (NCD). Provide significant intellectual and strategic input for drug development programs. As a member of project-oriented multifunctional development teams, will provide pathology scientific and intellectual input to project teams and guide project-related pathology support and investigative efforts. Function as a study pathologist/toxicologist on preclinical safety and pharmacology studies, review experimental protocols, provide gross and microscopic examinations of tissues (peer reviews) and aid in the evaluation and reporting of pathology results.
Oversite of all pathological aspects of preclinical safety studies. Work accurately and efficiently with other scientists within NCD. Identify and lead collaborative scientific efforts with internal, external and academic investigators. Initiate and formulate plans for development of new technologies for anatomic and clinical pathology that can be applied to investigative approaches in the toxicological sciences to improve the success of drug discovery efforts
Contribute to the identification of new biomarkers using clinical pathology tools and assist in the design and execution of appropriate validation studies. Provide leadership as a Toxicology/Pathology representative on Discovery/Development project teams.
Responsibilities (% of time):
Provide high-level advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
Review and approve pathology sections of preclinical safety/pharmacology study protocols, reports, and associated nonclinical summaries, regulatory submission sections and associated documentation, as well as abstracts/manuscripts for publication.
Conduct pathology peer reviews.
Maintain up-to-date toxicological pathology plans for all
projects/programs/products, including listings of studies, timelines, status and costs; update and refine as necessary.
Provide scientific/technical due diligence support for Business Development activities as required.
Prepare for and participate in regulatory agency interactions.
- DVM/VMD (or equivalent), PhD in a related field and a Board Certification in Pathology.
- 10+ years industry-related experience in preclinical drug development working within the pharmaceutical industry, with at least 5 years of experience in the field of toxicological pathology.
- Strong scientific record with proven pharmaceutical industry-related expertise as an investigative-toxicological pathologist
- Knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
- Experience in providing formal scientific/technical due diligence support for Business Development activities.
- Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
- Expertise in clinical pathology preferred.
- Experience in preclinical safety study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, and safety pharmacology.
- Excellent written and verbal communication skills.
- Fluency in written and spoken English is required.
Location/Region: Lexington, MA