Senior Biomarker Scientist
Senior Biomarker Scientist
The Biomarker Scientist will serve on a Compound Development Team (CDT) as the Translational Research group representative and will be the leader for the Translational Research and Biomarker strategy for the project. This position has several main functions. The Biomarker Scientist will enrich oncology translational/biomarker projects through interaction with the Translational Research group and external leaders to ensure common scientific standards for their project. The Biomarker Scientist will establish external scientific collaborations as needed, and will manage the experimental plan, timelines, deliverables, scientific outlines of the contracts/material transfer agreements/or research plans and will communicate results to the broader project teams when such collaborations are finalised
Develops and drives the Translational Research/biomarker strategy for specific Genmab projects.
Responsible for communicating this TR strategy to CDT, CDT subteams, and the broader TR and research organizations across Genmab.
For early programs, the TR leader will be responsible for overseeing the TR strategy that will ultimately lead to IND submission and approval and preparation for clinical development.
For late stage programs, the TR leader will be responsible for overseeing the TR strategy that contribute to clinical development and development decision making (ie: dose selection using PD markers, patient selection using predictive biomarkers, indication selection based on translational research data, etc).
Establishing and maintaining collaborative relationships with internal and external functional experts that can contribute to the TR strategy.
Regular reporting of TR/Biomarker data to the CDT and Genmab senior management.
Responsibility for the Translational/Biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Reports
Managing the outstanding or in-house coordination of proposed analysis within clinical trials.
Compliance and meeting projected timelines for project deliverables (e.g. protocol outlines, protocols, informed consent, strategy documents, analysis reports, etc.)
Must be capable of working with international project teams, and travel will be approximately 25%.
Skills & Experience
The Biomarker Lead will hold a Ph.D. or an M.D./Ph.D. in Molecular Biology or related field with at least five (5) or more years of applicable biomarker, program management, clinical trial and/or research experience.
This person will have a strong background in tumor biology and three or more years of pharmaceutical or biotechnology industry research experience.
The candidate will have a strong publication record demonstrating relevant experience in clinical trials, early drug development, drug discovery or biomarkers.
The candidate must have strong communication skills and sufficient experience in drug discovery and/or early development to represent a diverse biomarker group on a compound development team (CDT) and to communicate goals and deliverables to senior management and governance committees throughout Genmab.
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