Early Clinical Development Expert
- Experience Level
- Senior Management
Are you an expert in Translational Medicine, Biomarkers or Precision Medicine?
Do you have extensive experience in drug development and a deep knowledge of Oncology?
I am collaborating with an exciting commercial stage biotech company, we are currently seeking a expert Clinical Biomarker Lead for oncology drug development projects to be based remote across the EU.
We seek a positive, proactive, expert capable of building understanding of diseases and drugs by developing and applying innovative translational strategies (including biomarkers, clinical pharmacology, pharmacometrics and digital approaches) across the entire early development pipeline.
You will be responsible for driving projects across first-in-man, proof of pharmacological principle (PoPP), proof of clinical principle (PoCP) and proof of clinical concept (PoCC) up to submission.
Please read further to learn more.
Tasks and Responsibilities:
- As a leader of the Early Clinical Development team, you will define high quality and innovative clinical biomarker strategies.
- Through such biomarker strategies, you enable your projects to achieve important early clinical milestones.
- You will be accountable for the successful implementation of the biomarker strategy in clinical studies, in close collaboration with internal and external partners.
- You will design and execute exploratory translational medicine studies to ensure a better characterization of patient populations or to qualify biomarkers in close collaboration with internal scientists and leading external experts.
- You will lead academic and industrial consortia.
- You will lead the implementation of Precision Medicine concepts in assigned projects, which may include the development of Companion Diagnostics.
- You will also provide input into the preclinical identification of candidate biomarkers and the assessment of their usefulness during clinical development.
- You will have the opportunity to represent Translational Medicine & Clinical Pharmacology in strategic project teams including agency meetings.
- Medical degree
- Oncology expertise
- Appropriate scientific and individual qualification, including postdoctoral experience of several years and working experience in the development and implementation of biomarker concepts in a pharmaceutical, Biotech or CRO company.
- Expert-level disease-area knowledge with strong scientific knowledge of the pathophysiology and the main therapeutic modalities currently approved or in clinical development
- Knowledge and experience of the drug development process and a clear understanding of the applicable regulatory requirements is advantageous
- Personal track record in the implementation of biomarkers in drug development with an understanding of the clinical application of such markers, their evaluation and analysis, and the linkage between the biomarker and clinical endpoints
- Evidence of strategic and creative thinking, a team-oriented attitude, solid negotiation skills and strong team-working competencies to collaborate successfully in a matrix environment
- The ability to communicate effectively with internal and external experts and opinion leaders
- Competitive Basic Salary
- Enhanced bonus scheme
- Pension program
- Flexible remote working
- Family company culture
- Visibility and autonomy
To learn more, reach out via the contact details below for an honest and confidential discussion.
Email: vdessena (at) barringtonjames.com