Translational Medicine & Biomarker Lead - Precision Medicine
- Experience Level
- Experienced (non-manager)
Senior/Principal Translational Medicine & Biomarker Lead - Precision Medicine
Are you an expert in Precision Medicine, Biomarkers or Translational Medicine? Do you have extensive experience in Companion Diagnostic (CDx) as well as clinical drug development, and a deep knowledge of Oncology and other relevant disease areas?
We are currently seeking a TMCP Precision Medicine Lead for the implementation of Precision Medicine/CDx concepts in drug development programs to be based in Germany.
You will join a global organisation that builds understanding of diseases and drugs by developing and applying innovative translational strategies (including biomarkers, clinical pharmacology, pharmacometrics and digital approaches) across the entire clinical development pipeline.
Tasks and Responsibilities
- Advise project teams on Precision Medicine/CDx strategies, e.g. regarding patient selection strategies, clinical trial design and identification & application of biomarkers predictive for drug response from a CDx perspective.
- Be accountable for the successful implementation of CDx in drug development programs to ensure timely submission of drug and associated CDx test in close collaboration with external CDx partners as well as with internal functions
- Support clinical teams regarding CDx in internal decision-making committees and in strategic discussions, including agency meetings.
- Provide internal advice and support through the CDx Center to enable decision making regarding appropriate CDx opportunities.
- Represent the company in Joint Project teams with external CDx partners.
- Support qualification and management of third party laboratories and IVD partners, support CDx provider audits to ensure third party QC/QA and regulatory compliance.
- Contribute to early and late stage CDx-related topics in in-licensing opportunities, incl. due diligence and deal execution.
- Monitor the external CDx landscape for emerging opportunities, technologies and trends and changes in regulation/legislation.
- MD/ PhD in Life Sciences (focus on Precision Medicine/CDx)
- Several years of working experience in the development and implementation of biomarker/CDx concepts in a pharmaceutical or diagnostic company
- Expert-level knowledge and experience in Precision Medicine, CDx and clinical drug development, as well as a clear understanding of the applicable regulatory requirements
- Profound disease-area knowledge (in particular Oncology) with strong scientific knowledge of the pathophysiology and the main therapeutic modalities currently approved or in clinical development is advantageous
- Personal track record in the implementation of biomarkers/CDx assays 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
- The ability to build relationships with internal and external experts and opinion leaders
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