Scientific Director, Clinical Pathology
Core
Provides expert scientific interpretation and integration of clinical pathology data from nonclinical development studies to support drug safety assessment and regulatory submissions.
Role type
Senior IC veterinary clinical pathologist (toxicology)
Builds
Nonclinical safety assessment data and regulatory dossiers
Domain
Biopharmaceuticals / Nonclinical Drug Development Sciences
Required skills
Comparative clinical pathology, GLP regulations, toxicology, cytology, bone marrow aspirates, urine sediment, exploratory biomarker selection, regulatory submissions, cross-functional team leadership
Preferred skills
MS or PhD, ACVP board certification, industry experience, scientific publishing
Technologies
None stated
Responsibilities
Review non-GLP and GLP study protocols and provide input into clinical pathology endpoint design; Prepare scientifically rigorous clinical pathology reports for regulatory submissions; Serve as independent scientific reviewer for outsourced toxicology studies; Provide expert consultation on complex findings including cytology and biomarkers; Collaborate with NDDS colleagues to optimize clinical pathology resources; Evaluate and apply new scientific methodologies to resolve toxicity-based issues
Seniority
Senior, hands-on IC with leadership potential