Hiring company: Gilead
Gilead Sciences is seeking a veterinary anatomic pathologist motivated by impacting the portfolio across drug discovery and development. As a member of the Nonclinical Safety and Pathobiology (NSP) group, responsibilities will include helping assess 1) target safety, 2) on-target pharmacology, and 3) off-target effects from project inception to NDA/MAA filings. Examples of therapeutic modalities include small molecules, antibodies, ADCs, and CAR-T. Responsibilities include the design and interpretation of exploratory (non-GLP) studies, GLP studies, and regulatory communications.
Specific Responsibilities and Skills:
Candidates should have a strong track record of partnering with scientific colleagues to identify and solve critical pathology issues in drug discovery and development.
Responsibilities:
Provide pathology expertise and guidance while working closely with project toxicologists to design studies, interpret data and make decisions related to nonclinical safety projects.
Perform pathology evaluation and interpretation of early exploratory and investigative toxicology studies.Perform peer review of non-GLP and GLP studies.
Interpret and communicate findings to cross-functional project teams, senior management, and regulatory agencies.
Work closely with project toxicologists to investigate mechanisms of toxicity and identification of translational biomarkers.
Requirements:
The successful candidate will be a DVM with board certification (ACVP/ECVP) in veterinary pathology, PhD or MS in Pathology or closely related discipline.
10-15 years industry experience of toxicologic pathology.
Good understanding of the drug discovery, development and regulatory processes, including experience working directly on drug development project teams and Regulatory submissions.
Demonstrated issue-resolution experience.
Working knowledge of modern pathology laboratory technologies, including assay development, application and interpretation.
Preference:
American Board of Toxicology (A.B.T.) certification desired.
Excellent verbal and written communication skills to a variety of audiences including authorship of regulated pathology reports.
Ability to work independently and collaboratively on cross-functional projects teams.