Translational Research Scientist

Employer
Location
Utrecht, Netherlands
Salary
Competitive salary and benefits
Posted
May 28, 2018
Closes
Jul 28, 2018
Education
MD, MD / PHD
Hours
Full Time

Translational Research Scientist

The Translational Research (TR) lead scientist will serve on a multidisciplinary 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. In addition, the TR lead scientist will be part of the Joint Development Team (JDT) to align translational research strategies and clinical biomarker activities between Genmab and an external partner. This position has several main functions.

The TR lead will enrich translational/biomarker projects in oncology through interaction with the Translational Research Department, the New Products Group and the New Formats & Technology Group as well as external leaders to ensure common scientific standards for their project. The TR lead will establish external scientific collaborations as needed, and will be responsible for managing scientific content and execution of research agreements with external collaborators.

Key Accountabilities

Develops and drives the TR/biomarker strategy for the (pre-)clinical development of a novel therapeutic antibody compound designed to enhance anti-tumor immunity.

TR lead scientist will be responsible for designing, overseeing and executing the translational research package supporting the first-in-human trial (functional characterization of our antibody therapeutics, indication prioritization, IND enabling pharmacology studies, biomarker identification, biomarker strategy first-in-human trial)

TR lead scientist will contribute to regulatory documentation and interactions, ultimately leading to IND/CTA submission and approval and preparation for clinical development.

Responsible for establishing the TR and clinical biomarker strategy for a novel therapeutic antibody together with the relevant counterparts from an external partner.

Responsible for communicating the TR and clinical biomarker strategy to CDT/JDT, CDT/JDT subteams, and the broader TR Department and other research departments across Genmab.

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 TR leadership team and Genmab senior management.

Responsibility for the Translational/Biomarker sections in Clinical protocols, Investigator Brochures, Compound Development Plans generation of Clinical Study Reports

 Additional responsibilities include:

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 15-20%.

Skills & Experience

A Ph.D. or an M.D./Ph.D. in Immuno-Oncology or related field with at least five (5) or more years of applicable biomarker, program management, clinical trial and/or (translational) research experience.

A strong background in tumor biology and immunology, and three or more years of pharmaceutical or biotechnology industry research experience.

Capacity to (work with bioinformaticians to) analyze large omics-type datasets (e.g. from next generation sequencing).

A strong publication record demonstrating relevant experience in early drug development, translational research, biomarkers or clinical trials.

Strong communication skills and sufficient experience in drug discovery and/or early development to represent a diverse TR and biomarker team in a CDT/JDT and to communicate goals and deliverables to senior management and governance committees throughout Genmab.

Experience in guidance of research associates and scientists

A ‘getting things done’ mentality, pro-active, enthusiastic and goal orientated.

Excellent verbal and written communication skills in English.

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