Seeking a Director, Companion Diagnostics Pathology who will provide leadership and expertise in human disease pathology and molecular pathology to support the clinical development of tissue-based companion diagnostics for oncology drug candidates. As a member of the development project teams he/she will have the opportunity to work in a highly collaborative environment and to support projects throughout clinical development.
- 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 for clinical development studies:
1. Direct the development, outsourcing and validation of clinically applicable tissue based assays. Assists in the development of assay protocols as needed.
2. 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 development project teams and ensure access to state of the art tissue based techniques and samples for target pathway evaluation in human disease:
1. 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.
2. Evaluate the scientific basis and clinical applicability of the proposed assays, their validation status and any related technical issues.
3. Assume responsibility for the assessment and scoring of specimens and the preparation of reports summarizing the data, analysis and interpretation of findings.
4. 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.
- Highly 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:
1. Awareness of the challenges of implementing tissue based biomarker and diagnostic technologies in the clinical setting
2. Direct experience in development, outsourcing and validation of clinically applicable tissue based biomarker assays
- A proven Molecular Pathology track record with credible publications and Pathology support for research and clinical science:
1. Demonstrated expertise in tissue-based analysis such as in situ hybridization, immunohistochemistry, fluorescence applications, laser capture microdissection
2. Expertise with human diseases and evaluation of disease pathogenesis with tools such as experimental mouse models
3. 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
- U.S. Citizen/green card holder