Role Overview

A4P (a LabConnect company) has an opening within our Functional Service Provider solutions division. We are looking for a highly motivated and creative Senior Scientist with strong expertise in developing, validating and implementing tissue-based (immuno-)oncology biomarker assays using techniques such as immunohistochemistry (IHC), multiplex immunofluorescence (mIF) and spatial proteomics/transcriptomics. These tissue biomarker assays will be deployed in our cancer immunotherapy clinical trials to support the discovery and validation of pharmaco-dynamic and patient selection biomarkers, in view of companion diagnostics (CDx) development.

The selected candidate will work in close interaction with theTranslational Medicine (TM) departmentTM Leads, TM scientists and members of the Clinical team to select biomarkers, ensure access to state-of-the-art technologies and evaluate their scientific basis and clinical applicability. He/she will lead the development and outsourcing of clinically applicable biomarker assays and ensure the assays are suitably validated. He/she will also be responsible for data analysis and interpretation, including running relevant statistical tests. Finally, in close interaction with the TM Lead, TM Scientist and the Clinical team, he/she will contribute to building the scientific rationale supporting the clinical strategy.

This is a remote position, travel to onsite location 2-4 times per year.

Responsibilities

• Leading the development, validation and clinical implementation of tissue-based biomarker assays using IHC, mIF and related techniques across clinical studies, in close interaction with the Biomarker Strategy team.
• Ensuring the feasibility of such assays in a clinical setting and overseeing the selection of external analytical laboratories (CROs), monitoring of assay transfer and validation, troubleshooting, supervising of clinical sample analyses and analysis of the data.
• Writing and reviewing scientific documents, including technical reports and scientific publications in support of the different clinical programs.
• Supporting the development of biomarker strategies for diverse projects.
• Performing complex data analysis and interpretation from pharmacodynamic and patient selection biomarker testing across several clinical programs.
• Mentoring the experimental work of research assistant(s).

Professional Experience and Qualifications

• PhD, MD/PhD in Cancer Immunotherapy, Immunology or Molecular Biology/Pathology with a minimum of
• 2 years of relevant post-doctoral or industrial research experience in development and/or validation of human tissue biomarker assays in the context of clinical trials.
• Experience with the discovery and characterization of biomarkers using IHC, mIF, spatial proteomics/transcriptomics or related techniques on human tissue specimens.
• Experience with image analysis solutions such as Visiopharm and Halo is recommended.
• Experience with single cell technologies, flow cytometry, proteomics and other molecular biology techniques is a plus.
• Experience in qualification/validation, development, and outsourcing of clinically applicable biomarker assays and analyzing corresponding data.
• Experience with patient selection and/or Companion Diagnostic (CDx) assay development is a plus.
• Understanding of GCP/GCLP guidelines and current global regulations.
• Experience in drug development and clinical trial design and monitoring is desirable.
• Previous experience in Biotech/Pharma industry and oncology drug development is a plus.
• Experience in people management a plus.
• Excellent English (oral and written), French is a plus.
• Ability to work independently while collaborating effectively with internal and external stakeholders.
• Solution-oriented with strong project, organization and problem-solving skills.
• Resilience with the ability to adapt to changes in priorities and to work effectively on multiple immune-oncology programs in a fast-paced environment.