Pathologist

• This role provides scientific and strategic leadership to embed AI/ML-enabled pathology and digital pathology capabilities into Takeda’s nonclinical research workflows.
• This role will work with the NCSP iDigPath team to advance AI/ML applications that enable quantitative, high-content analysis of pathology data to improve sensitivity, reproducibility, and translational relevance of tissue-based endpoints to contribute to the validation of novel targets, guide the design of efficacy and safety assessment strategies, and ensure robust integration of pathology insights into program advancement and governance decisions.
• This role will implement workflows to integrate digital pathology into target validation, efficacy and safety assessment strategies to support program advancement and decision-making, primary evaluation and peer review of pathology specimens and data and study reports.

Accountabilities:

• Serve as an NCSP Project Pathologist and/or Project Toxicology representative on project teams within Global Pathology (NCSP), providing anatomic/clinical pathology and toxicology expertise and collaborating with project and cross-functional R&D leaders to support transition of programs into development.
• Lead pathology contributions to target validation and mechanism-of-action understanding through integrated interpretation of pathology, pharmacology, and biomarker data.
• Provide scientific leadership for fit-for-use qualification of AI/ML pathology tools and digital endpoints on efficacy, translational and toxicology studies, including governance for data quality, and model performance.
• Provide scientific direction and pathology expertise for IHC, ISH, and spatial endpoints, in collaboration with NCSP Investigative Pathology (iPath) and Toxicology labs (iTox), DMPK, and Drug Discovery Units.
• Perform integrative macroscopic and microscopic primary reads and peer reviews of animal tissues from toxicology, investigative, translational, and discovery studies to effectively communicate pathology and safety data (and implications) to broad audiences via study reports, regulatory documents, and project meetings; provide recommendations that inform project strategy and decisions.
• Author and review regulatory documents (BB, IND, IB, DSUR, BLA, MAA, NDA, JNDA) for technical accuracy and regulatory adequacy and provide response to health authorities on toxicology/pathology issues, ensuring consistent, defensible scientific positions.
• Represent Takeda in local/national toxicology/pathology meetings and participate in professional society committees, working groups, and cross-industry consortia.

Education & Competencies (Technical and Behavioral):

• DVM (or equivalent) and Ph.D.
• Board certified by the American College of Veterinary Pathologists (ACVP), European College of Veterinary Pathology (ECVP) or Japanese College of Veterinary Pathology (JCVP).
• Proficiency in veterinary anatomic and/or clinical pathology
• 10+ years pharmaceutical drug development experience including as a project team representative and due diligence activity.
• Experience with alternative modalities specifically including oligonucleotides, antibodies and conjugates, small molecules and alternative routes of administration is desired.
• Strong decision-making, complex problem solving, critical data analysis, and interpretation.
• Excellent communication skills (written and oral).
• Ability and desire to take on leadership roles.
• Working knowledge of digital pathology platforms (Halo-link, Halo, Visopharm, Patholytix, Pristima/Provantis and Benchling ELN) and quantitative image analysis workflows
• Track record of leading innovative or transformational initiatives, particularly in digital pathology, computational biology, or translational science
• Strong leadership, collaboration, and mentoring experience consistent with a Director-level role