Role Description
Join Amgen’s Mission of Serving Patients. Amgen is seeking a Pathology Senior Director within the Discovery and Toxicologic Pathology of Translational Safety Regulatory Science function. The role has a focus on digital pathology to accelerate the execution of computational pathology workflows inclusive of AI/ML model development discovery programs.
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Responsible for ensuring the reliable execution of computational pathology workflows, including FAIR data curation, quality control, and analysis activities.
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Ensures that imaging data, metadata, annotations, and analysis outputs are fit for purpose for AI development and scientific biologic conviction.
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Functions as a project pathologist, supporting the advancement of the pipeline by designing, executing, and interpreting toxicology studies.
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Assesses safety risks and contributes to project strategy across all phases of Research and Development, as well as for marketed products.
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Collaborates closely with Toxicology and Study Management and CRO partners.
Key Responsibilities
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Ensure incoming datasets are delivered according to defined data formats, metadata standards, and project requirements.
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Translate scientific and model development requirements into structured dataset preparation tasks with pathology scientists and pathologists.
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Ensure imaging data, annotations, and metadata are suitable for downstream AI/ML model development, validation, and scientific analysis.
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Execute computational pathology workflows across AI model development and discovery projects for image analysis workflows.
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Identify opportunities to improve data workflows, tooling, and operational processes within computational pathology.
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Stay informed about emerging data management practices, digital pathology technologies, and AI data standards.
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Provide pathology expertise to the design and conduct of GLP and non-GLP nonclinical safety studies.
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Serve as a contributing author to pathology sections of regulatory documents such as INDs, NDA/BLAs, IBs, and respond to Health Authority questions.
Qualifications
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DVM and 7 years of pathology or toxicology experience OR
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Master’s degree and 10 years of pathology or toxicology experience OR
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Bachelor’s degree and 12 years of pathology or toxicology experience.
Preferred Qualifications
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DVM, Board Certification in Veterinary Anatomic Pathology (DACVP or comparable credentialing body) and PhD in pathology or toxicology.
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At least 15 years’ experience in the pharmaceutical sector as a discovery and toxicologic pathologist.
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5 years’ experience integrating pathology data into bioinformatics efforts in a pharmaceutical environment.
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Experience in pathology data management within pharmaceutical environments is highly desirable.
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Demonstrated experience working with large-scale imaging datasets and associated metadata in distributed or cloud environments.
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Experience with annotation platforms, digital pathology pipelines, or whole-slide image analysis environments.
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Familiarity with IHC assay workflows and digital slide scanning.
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Experience in interpreting target discovery pathology and toxicology studies.
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Strong problem-solving skills and solution-oriented mindset.
Benefits
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A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
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Group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
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A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
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Stock-based long-term incentives.
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Award-winning time-off plans.
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Flexible work models where possible.
Salary Range
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is 249,288.85 USD - 337,273.15 USD. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.