Overview
The Principal Clinical Study Manager is a senior individual contributor role providing leadership and strategic oversight for the global execution of complex Companion Diagnostics (CDx) clinical studies. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. As the Principal Clinical Study Manager, you will independently lead end-to-end study planning and operational delivery, ensuring alignment with regulatory requirements, timelines, and quality standards. You will serve as the central point of accountability for study execution, collaborating cross-functionally and with external partners to drive progress, resolve issues, and achieve critical program milestones. This position reports to the Director, Clinical Development and is part of the Global Clinical Affairs Team located in Newcastle, UK and will be an on-site role.
Responsibilities
* Lead global IVD clinical development programs from concept to commercialization, ensuring strategic alignment with corporate goals, regulatory requirements, and portfolio priorities.
* Oversee cross-functional site and vendor strategy, including selection, contract negotiation, performance management, and issue resolution to support enterprise-wide clinical trial execution.
* Develop and implement operational frameworks integrating timelines, budgets, resource planning, and risk management to drive efficient and compliant program delivery.
* Establish governance and communication structures to align internal and external stakeholders, promote transparency, and foster a collaborative, accountable culture.
* Drive performance analytics and quality assurance, leveraging data insights to optimize trial execution, support regulatory submissions, and ensure audit readiness.
Qualifications
* Bachelor's degree in Life Sciences, Healthcare, or a related field with 10+ years' experience in clinical research, or a Master’s/Doctoral degree with 8+ years of experience in the same field.
* In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with products intended for the US and EU markets.
* Demonstrated ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
* Ability to critically review and interpret scientific and clinical trial data, and oversee the scientific aspects of study protocols and reports.
* Excellent leadership, communication (written and verbal) and interpersonal skills for managing a team and collaborating with cross-functional stakeholders.
* Experience in study designs for in vitro diagnostic technologies (IVD) is highly preferred, specifically for Digital Pathology and Immunohistochemistry (IHC) & In Situ Hybridization (ISH).
* Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs is a plus.
* Professional certification in Clinical Research (e.g., SoCRA, ACRP) is a plus.
About Leica Biosystems & Benefits
Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Our benefits information can be found via the Danaher Benefits Info page. Learn about the Danaher Business System which enables our work.
Additional Information
At Leica Biosystems, we are committed to a culture of belonging where diverse perspectives matter. We strive to innovate with speed and impact in life sciences, diagnostics, and biotechnology. The mission is to advance cancer diagnostics and improve lives. This role is on-site in Newcastle, UK.
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