Principal Scientist - Clinical Biomarkers

Proclinical is seeking a dedicated Clinical Biomarker Principal Scientist. This role involves defining biomarker strategies, monitoring biomarkers in clinical trials and supporting cross-functional process optimisation. The successful candidate will also be involved in companion diagnostics development across various therapeutic areas.

Responsibilities:

• Define clinical biomarker strategies and establish biomarker plans for target engagement, pharmacodynamics, mechanism of action and patient selection.
• Anticipate the need for companion diagnostic and adapt biomarker strategy accordingly.
• Support the translational team in defining the translational strategy to guide the clinical biomarker strategy.
• Monitor clinical implementation and validation of biomarkers.
• Implement biomarker plans for clinical trials into clinical study documentation.
• Work closely with clinical operation teams and CROs to monitor ongoing biomarker activities.
• Identify, select and validate CROs for biomarker validation and analysis.
• Communicate effectively across the organisation within REED and with Clinical Development, Project Management, Regulatory, R&D and BD.
• Interface with regulatory authorities, as appropriate, in support of development objectives.
• Maintain knowledge of national and international guidelines including industry standards for Good Laboratory/Clinical Practice.

Key Skills and Requirements:

• PhD + Post doc in a life science field, oncology or immuno-oncology are preferrable.
• Strong knowledge of translational science and clinical biomarkers in drug development.
• Proven knowledge of the correct application of several different scientific technologies into strategies for translational research.
• Deep understanding of NGS and its application for companion diagnostics.
• Familiarity in companion diagnostic development and approval.
• Comfortable working in a fast-paced environment and leading a matrix team.
• Ability to recognise, articulate and accept calculated risks to make informed decisions.
• Working knowledge of all functional areas of drug development.
• Strong scientific written and interpersonal communication.
• Expert familiarity with clinical and laboratory practices.
• Good experience working with CROs.

Interested or know someone who might be? Reach out to James Hume using the following:

✉️ j.hume@proclinical.com

📞 020 8167 5468

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.