Translational Research Project Scientist
Translational Research Project Scientist
The TR project scientist will work together with the TR project leader and other functional teams within Genmab to deliver Translational Research and Biomarker studies for Genmab’s antibody drug-conjugate product HuMax-TF-ADC (tisotumab vedotin), currently in development for treatment of various solid tumors, like cervical cancer.
The TR project scientist will work independently and in collaboration with other translational research team members to develop integrated translational/biomarker plans. This includes scientific and clinical justifications and rationales for proposed preclinical and clinical biomarker testing, timelines, and operational aspects of implementing the planned translational research strategies. The TR project scientist will also lead pre-clinical pharmacology and biomarker studies and apply these data into clinical translational/biomarker studies in Genmab’s clinical trials.
The TR project scientist will generate new translational/biomarker proposals, manage ongoing studies, and communicate translational/biomarker project data to the leadership of the TR group.
You will work in multidisciplinary international project teams to discover and develop antibody therapeutics. As a Project Scientist in the Translational Research (TR) group you will guide the development of ground-breaking new medicines from concept to the clinic by the design and execution of cutting-edge research.
Develops and operationalizes the Translational Research/biomarker strategy for HuMax-TF-ADC (tisotumab vedotin).
Responsible for pre-clinical research (both in vitro and in vivo) to validate new indications, drug combinations,or biomarkers for application in clinical studies.
Responsible for collating and analyzing exploratory biomarker/translational data from clinical studies.
Responsible for reporting scientific results in patents, publications, regulatory documents (e.g. CTA/BLA) and product-development reports.
Operates as Translational Study Lead for one or more of the HuMax-TF-ADC clinical trials; responsible for communicating and guiding the translational/biomarker plans for that trial
The TR project scientist is responsible for designing and executing the TR strategy for assigned clinical trials, in order to contribute to clinical development (i.e.: dose selection using PD biomarkers, patient selection using predictive biomarkers, indication selection based on translational research data, etc.).
Maintaining collaborative relationships with internal and external functional experts that can contribute to the TR strategy.
Must work closely with TR/biomarker laboratories to coordinate biomarker testing, results, and analyses
Regular reporting of TR/Biomarker data to the TR Lead, TR unit, and Genmab research organization.
Responsibility for the Translational/Biomarker sections in clinical protocols, informed consents, investigator brochures, Statistical Analysis Plans, laboratory statements of work, technical documentation of results, and Clinical Study Reports
Managing and coordinating the planned biomarker testing, results reporting, and proposed analysis within assigned clinical trials.
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 TR/Biomarker Scientist will hold a Ph.D. or an M.D./Ph.D. in Molecular Biology or related field with at least three years of applicable biomarker, clinical trial and/or research experience.
Have a strong background in tumor biology and immunology/immune-oncology, and three or more years of pharmaceutical or biotechnology industry research experience.
Experience in Oncology Translational Research or Oncology Clinical Biomarker Research
Experience with large omics-type datasets (e.g. from next generation sequencing).
Know how to design in vivo models to assess efficacy of single agent or combination therapies.
Have a strong publication record demonstrating relevant experience in clinical trials, early drug development, drug discovery or biomarkers.
Have strong communication skills and sufficient experience in translational research to represent a diverse biomarker group on a global clinical trial management team and to communicate goals and deliverables to other expert fields throughout Genmab.
Have a ‘getting things done’ mentality, are pro-active, enthusiastic and goal-orientated.
Have excellent verbal and written communication skills in English.
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