AbbVie

Pathologist-Director, Companion Diagnostics Pathology

Employer
AbbVie
Location
South San Francisco, CA, United States
Posted
Nov 20, 2020
Ref
2008814
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Specific Job Requirements:

AbbVie is currently offering a unique opportunity for a highly motivated individual to join our team as a Pathologist-Director, Companion Diagnostics Pathology. The Companion Diagnostics Pathology Group resides within the Precision Medicine group and helps support CDx development across Abbvie. The successful candidate will provide leadership and expertise in human disease pathology and experimental pathology to support the development of tissue-based companion diagnostics for oncology and immunology drug candidates. The successful candidate will have the opportunity to work in a highly collaborative environment and to support projects throughout clinical development.

Responsibilities:
  • Lead the identification and development of tissue-based biomarkers, including their characterization and validation (biomarker prevalence, clinical utility for patient selection/stratification, relevant cutoffs, etc.) and the proposed pathology assays (specificity and sensitivity, scoring system, etc.).
  • Design, implement and oversee pathology-based biomarker and diagnostic testing and data analysis:
    • Direct the development, outsourcing and validation of clinically applicable tissue-based assays. Assist in the development of assay protocols as needed.
    • 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:
    • Implement technologies and/or methodologies as needed, via a combination of in-house efforts and the use of CROs or other external expertise using techniques such as in situ hybridization, immunohistochemistry, IHC multiplexing, fluorescence applications, use of image analysis algorithms, laser capture microdissection, RNAseq, qPCR, etc.
    • Evaluate the scientific basis and clinical applicability of the proposed assays, their validation status and any related technical issues.
    • Assume responsibility for the assessment and scoring of specimens and the preparation of reports summarizing the data, analysis and interpretation of findings.
    • 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.
  • Lead and participate in project development teams or sub-teams as needed. Coordinate with appropriate team members to advance projects efficiently.

Qualifications

Qualifications:
  • Experienced pathologist (MD, PhD, or DVM degree) with 8+ years of relevant post-doctoral academic, clinical and/or industry pathology experience. Board certification in the United States is desirable but not required.
  • In depth experience with the discovery, characterization, clinical validation and utilization of tissue based biomarkers and potential diagnostics:
    • Awareness of the challenges of implementing tissue based biomarker and diagnostic technologies in the clinical setting
    • Direct experience in development, outsourcing and validation of clinically applicable tissue based biomarker assays
  • A proven Experimental Pathology track record with credible publications and Pathology support for research and clinical science:
    • Demonstrated expertise in tissue-based analysis such as in situ hybridization, immunohistochemistry, fluorescence applications, laser capture microdissection
    • Expertise with human diseases and evaluation of disease pathogenesis with tools such as experimental mouse models
    • Expertise with image analysis software and algorithm design
  • Demonstrated excellence in independently leading and conducting research and ability to summarize information/data in a concise, easy to understand manner
  • Excellent leadership skills including mentoring, motivation and delegation
  • Excellent verbal and written communication and presentation skills in English
  • High level of initiative and ability to work independently
  • High level of business awareness

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.