Scientific Director, Clinical Pathology
Core
Provides expert scientific interpretation and integration of clinical pathology data from nonclinical development studies to support 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, pharmacokinetics, regulatory submissions, cross-functional team leadership, scientific problem-solving, data integration
Preferred skills
ACVP board certification, MS or PhD, industry experience, publication record
Technologies
None explicitly listed
Responsibilities
Review non-GLP and GLP study protocols and input into clinical pathology endpoint design; Prepare scientifically rigorous clinical pathology reports for regulatory submissions; Serve as independent reviewer for outsourced toxicology studies; Provide expert consultation on complex findings (cytology, bone marrow, urine sediment, biomarkers); Collaborate to optimize clinical pathology resources across sites; Evaluate and apply new scientific methodologies to resolve toxicity issues
Seniority
Senior, hands-on IC with leadership potential