This role requires a senior board-certified veterinary pathologist experienced in toxicologic pathology and drug development. He/she will establish and lead a new functional pathology group within the Nonclinical (NCD) organization. This function will provide the scientific expertise in regulatory and investigative pathology assessments supporting late Discovery Research programs and all development programs within Shire’s portfolio. This role will be a member of the NCD Senior Leadership Team. He/she will provide broad multi-disciplinary expertise and drug development guidance across all of NCD and R&D functions and interact with scientists across several disciplines both within and outside Global Nonclinical Development (NCD). The successful leader will provide SME intellectual and strategic input for drug development programs and guide project-related pathology support and investigative efforts. This role and the emerging function will oversee all clinical and anatomical pathology endpoints used in nonclinical 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. This will demand collaborative interactions with other scientists within NCD along with external and academic investigators. This role will be expected to 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. Additionally the function will participate in the identification of new biomarkers using clinical pathology tools and assist in the design and execution of appropriate validation studies.
Responsibilities (% of time):
Provide senior-level leadership in establishing an SME pathology function within NCD and provide guidance 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, 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, and Board Certification in Pathology. PhD in a related field preferred.
- 15+ years industry-related experience in nonclinical drug development working within the pharmaceutical industry, with at least 8 years of leadership experience in the field of toxicological pathology.
- Strong scientific record with proven pharmaceutical industry-related expertise as an investigative and regulatory toxicological pathologist and drug development scientist.
- 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, such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
- Expertise in clinical pathology.
- Experience in preclinical safety study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, and safety pharmacology.
- Excellent written and verbal communication skills. Fluent in written and spoken English
Location/Region: Lexington, MA