Companion Diagnostics (CDx) Lead
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Hobson Prior are currently working with a global pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking a Companion Lead to join them on a 12 contract basis in Frankfurt.
- The candidate is able anticipate and mitigate risks, communicate in an open, transparent and timely manner, and take accountability in all CDx related aspects.
- The candidate can pick up, understand, define, and integrate specific requirements of global Companion Diagnostic development (FDA, EMA, PMDA, NMPA, etc…) in drug development programs where molecular testing is applied.
- The candidate can show strong inspirational leadership skills and needs to be able to deliver with high probability of success, with close attention to detail while adhering stringently to aligned budgets.
- This is a highly visible and interactive role requiring broad scientific understanding while integrating drug development and regulatory affairs into the proposed solutions.
- Active leadership of a cross-functional group of people is required.
- Commercialization experience considered an additional asset.
* Bachelor's degree with 10+ years of experience, master's degree with 5+ years, or a PhD with 3+ years of experience in companion diagnostics and biomarker research
* A PhD with 10 plus years of experience in bringing molecular based companion diagnostics to market, throughout development and registration. NGS-experience is a plus.
* Has led a dedicated team of experts focusing on CDx development strategies with a special emphasis on molecular testing
* Proactively and transparently consider regulatory requirements and CDx technology details, with the ability to distill and deliver, holistic and over-arching global CDx development plans across a number of development programs
* Strategically develop and implement molecular testing (preferably NGS) in clinical trials including both tissue and plasma-based testing strategies (other liquid biopsy strategies will also be considered). This includes implementation across broad geographies, minding specificities of regulatory agencies abroad.
* Support teams with the implementation and improvement of molecular testing strategies at initiation of clinical trials, during trials, during approval process, at market entry and in the evolving market situation (diagnostic life-cycle management)
* Support regulatory activities required for the successful implementation of testing at initiation of clinical trials, during trials, during approval process, at market entry and in the market situation.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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