US-MA, In situ Diagnostics Lab. Pathologist 235963BR-MZ
In situ Diagnostics Lab. Pathologist
Global Drug Development
Research & Development
The Precision Medicine (PM) In situ Diagnostics Laboratory Pathologist is responsible for leading the development and validation of in situ and IHC diagnostic assays. The successful PM In situ Diagnostics Laboratory Pathologist is able to lead to the development and implementation of in situ and IHC tissue-based assays through their deep knowledge and expertise in pathology approaches across diverse human indications. Expertise in immunohistochemical and in situ assays, as well as in digital image analyses are required.
Responsible for developing in situ and IHC assays towards transfer to external laboratory and FDA IDE submission.
- Responsible for providing comprehensive analyses of IHC and ISH assays required for feasibility studies and assay validation in immuno-oncology field.
- Responsible for developing and accessing image analyses approaches and multi-analytic detection, including digital pathology platforms.
-Responsible for recommending appropriate cut-offs and interpretation algorithms associated with pathology review of IHC and ISH assays for specific tissue biomarkers
- Clinical pathology expertise in supporting the identification and feasibility testing of ISH tissue-based assays.
- Supports and can lead the identification and validation of external in situ partners and laboratories involved in CTAs for clinical trials and companion diagnostic development.
- Responsible for timely execution of assigned protein and in situ assay development for FPFV in GDD trials involving patient selection, stratification, pharmacodynamics, correlative studies and CDx development in clinical immuno-oncology.
- Supports regulatory submissions by acting as pathologist subject matter expert within the team . Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission.
- Contributes to the development, implementation and continuous improvement of processes supporting the Precision Medicine vision, mission and goals.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
D.O., M.D., or Ph.D with ABMGG certification
English - Oral and written communication
1. 5+ years of industry experience in pathology, in situ and tissue-based biomarker assay development.
2. 3+ years multi/cross functional successful team experience within an Oncology business unit
3. Expert skills to facilitate/optimize histopathology analyses and generating reports.
4. Excellent interpersonal and communication skills for effective internal and international collaboration.
5. Outstanding verbal and written communications. 6.CLIA laboratory/IVD development experience is an advantage.
7. Results driven and goal orientated personality. 8.Board certification or eligibility for board certification is an advantage and not required.
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