Pathologist, Director, Precision Medicine Pathology

3 weeks ago

South San Francisco, United States AbbVie, Inc Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Precision Medicine Pathology supports projects from Discovery through Companion Diagnostics across therapeutic areas. Pathologists are deployed to projects to provide expertise in human disease pathology, experimental pathology support and contribute to the development and interpretation of tissue-based assays.

Specific responsibilities can include:

* Contribute to or lead efforts to identify tissue-based biomarkers, including their

characterization, validation and use in the development of tissue-based assays.

* Contribute to or lead the design and interpretation of tissue-based studies investigating

aspects such as target biology, drug MOA, target pathway activation, pharmacodynamic

effects, biomarker prevalence, or drug distribution.

* Contribute to the design, validation and deployment of pathology assays, including the

determination of assay parameters such as specificity and sensitivity.

* Develop, validate and implement scoring paradigms for tissue-based assays
* Design, implement and oversee pathology-based biomarker and diagnostic testing,

including data analysis:

o Direct the development, outsourcing and validation of clinically applicable tissue-based

assays. Assist in the development of assay protocols as needed.

o Write the relevant pathology-based biomarker and diagnostics testing sections in drug

development and registration documents such as clinical study protocols, clinical study

reports, investigator brochures, and regulatory submission packages (INDs, NDA's,

BLA's).

* Provide pathology input to project teams and ensure access to state-of-the-art tissue-based

techniques and samples for target pathway evaluation in human disease:

o Implement technologies and/or methodologies via a combination of in-house efforts

and the use of CROs or other external expertise using techniques such as in situ

hybridization, immunohistochemistry (including multiplexed), image analysis, RNAseq,

qPCR, etc.

o Evaluate the scientific basis and clinical applicability of the proposed assays, their

validation status and any related technical issues.

o Assume responsibility for the assessment and scoring of specimens and the preparation

of reports summarizing the data, analysis and interpretation of findings.

o Collaborate with project teams from concept to reagent generation to quantitation and

approval plan for CDx as needed.

* Participate in the evaluation of external licensing or collaborative opportunities (including

CDx collaborations) and oversee internal components of shared programs.

* Participate in or lead project development teams or sub-teams. Coordinate with

appropriate team members to advance projects efficiently.

Qualifications

* Experienced pathologist (MD, DVM) with relevant post-doctoral academic, clinical and/or industry pathology experience -required
* Board certification in pathology (anatomic, clinical, combined, with or without additional specialization) - required
* PhD in relevant field of science -preferred, but not required

Additional Information

Applicable only to applicants

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