Note: The job is a remote job and is open to candidates in USA. Leica Biosystems, a Danaher operating company focused on cancer diagnostics, is seeking a Senior Manager, Clinical Science. The role oversees global clinical trial strategies, leads clinical scientists, drives study design and execution, ensures regulatory compliance, and supports the interpretation and dissemination of clinical research findings.
Responsibilities
- 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
Skills
- 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
- 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)
Benefits
- This job is also eligible for bonus/incentive pay.
- Paid time off
- Medical/dental/vision insurance for eligible employees
- 401(k) for eligible employees
- This position is eligible for a remote work arrangement in which you can work remotely from your home.
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