Sr. Manager, Clinical Science

Sr. Manager, Clinical Science (Global - Remote)

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Leica Biosystems, we're not just shaping the future of cancer diagnostics we're transforming lives. Our mission of "Advancing Cancer Diagnostics, Improving Lives" is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact.

In this role, you will have the opportunity to:

• Oversee the scientific planning and design of clinical studies for Digital Pathology, and Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx) and Medical Device, ensuring scientific validity and alignment with overall clinical strategy.
• Ensure the scientific rigor and accuracy of clinical protocols, case report forms, study reports, and other clinical documentation
• Serve as a key scientific liaison, working cross-functionally with R&D, Regulatory, Medical Affairs, and other teams to integrate clinical insights into product development and commercialization strategies.
• Collaborate closely with Regulatory Affairs to support regulatory submissions and interactions with regulatory agencies by providing scientific expertise and clinical study data interpretation
• Build, lead, and mentor a high-performing team of clinical scientists, providing mentorship, guidance, and fostering their professional development to ensure high performance and scientific excellence
• Establish and maintain strong collaborative relationships with internal cross-functional teams (e.g., R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, Data Management, Clinical Operations, Commercial) and external partners (e.g., CROs, investigators, key opinion leaders) to ensure successful clinical program execution.
• Manage the analysis and interpretation of clinical study data, contribute to the preparation of regulatory submissions, and guide the dissemination of research findings through publications, presentations, and internal reports.

The essential requirements of the job include:

• Bachelor's degree in Life Sciences, Healthcare, or a related field with 12+ years' experience in clinical research, specifically with significant experience in US and/or EU trials, or a Masters or Doctoral degree with 10+ years of same experience.
• 4+ years direct leadership experience, including experience managing clinical research scientists
• In-depth understanding of clinical study design and methodology 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

It would be a plus if you also possess previous experience in:

• 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
• Professional certification in Clinical Research (e.g., SoCRA, ACRP).