Description:

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

 

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you.  To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.  As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

 

Utilizing the technologies of Molecular Pathology, Genomics, Flow Cytometry, Immunochemistry, and Mass Spectroscopy, the Translational Molecular Biomarkers (TMB) is responsible for clinical biomarkers in all therapeutic areas and in all phases of clinical development at Merck Research Laboratories. The Molecular Pathology group has a critical role within TMB organization and is responsible for developing, analytically validating, and deploying histopathology-based biomarker assays such as single-plex immunohistochemistry and multiplex immunofluorescence to inform pipeline decisions for early and late phase clinical trials of all therapeutic areas, with a focus on Oncology and Immunology.

 

We are seeking for a highly motivated Senior Scientist with a doctoral degree (PhD) who has a strong knowledge of histopathology-based biomarker assays.

 

Candidate must possess scientific excellence and strong understanding of clinical biomarkers, ability to work independently with internal and external collaborators within a highly matrixed organization and excellent written and verbal communication skills to be able to clearly communicate scientific objectives and interpret data. Candidate should also have a strong interest in Translational Sciences. This individual will have a critical role in performing histopathology-based clinical assay development, analytical validation, and clinical sample analysis either internally or overseeing the work at Contract Research Organizations. The data generated will be used to assess likelihood of response to treatment and/or better understand biological mechanisms of disease and therapeutic resistance in support of Merck’s early and late phase clinical trials.   

 

Merck has a strong history and legacy for the early, strategic, and successful use of biomarkers in clinical development and this position offers an opportunity to impact the Merck’s impressive drug development pipeline by utilizing the power of histopathology based clinical biomarkers.

 

Key Responsibilities

  • Lead the development and analytical validation of histopathology-based (e.g., immunohistochemistry, multiplex immunofluorescence, fluorescent in-situ hybridization) assays for all therapeutic areas and all phases of clinical development.

  • Assist in the transition of biomarker assays from Discovery Research to Clinical Development by providing technical guidance on fit-for-purpose assay validation.

  • Deploy histopathology-based assays at external vendors for supporting Merck clinical trials in global scale, provide scientific oversight on clinical sample analysis ongoing at these vendors by ensuring the assay and data quality over time, and troubleshoot the potential issues efficiently.

  • Serve as a subject matter expert in tissue-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs on the implementation of these assays in clinical trials.

  • Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.

  • Write and review validation and bioanalytical assay final reports, publications, SOPSs, memos, etc.

Education Minimum Requirement: 

  • Doctoral degree (Ph.D.) in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry

Required Experience and Skills:

  • Ph.D. with at least 4 years of post-doctoral experience.

  • A minimum of 2 years of direct experience in histopathology-based assay development and validation, such as single-plex and multiplex immunohistochemistry (IHC), in-situ hybridization (ISH) and basic knowledge of morphology in histopathological samples.

  • Good understanding of clinical biomarkers.

  • Strong interpersonal, verbal, and written communication skills.

  • Ability to execute and thrive within a matrixed organization.

  • Being self-motivated and eager to learn and evaluate new technologies

Preferred Experience and Skills:

  • Implementation of immunohistochemistry-based biomarker assays in support of drug development.

  • Knowledge of drug development process and translational medicine.

  • Prior experience in the fields of oncology and immuno-oncology.

  • Prior experience working in a regulated laboratory setting (e.g., CAP/CLIA).

  • Experience in multiplex tissue-based spatial profiling assays (i.e., multiplex immunofluorescence, multiplex chromogenic immunohistochemistry)

  • Experience with image acquisition platforms (e.g., Leica Aperio, Hamamatsu, 3DHISTECH Pannoramic)

  • Experience with digital image analysis of histopathological samples (H&E and/or IHC stained) by using commercial image analysis software packages (e.g., Visiopharm, HALO).

  • Knowledge of using statistical software packages (e.g., Prism, SPSS).

About Merck:

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