Sr. Manager, Clinical Science

Danaher•Vista, CA

4d•Remote

About The Position

This leadership role is responsible for the oversight of all clinical trial strategies globally for Danaher Diagnostics. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. You will lead a team of clinical scientists, driving strategic study designs, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in these vital markets. This position is part of the Danaher Diagnostics, Leica Biosystems organization and will be a remote role. At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

Requirements

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

Nice To Haves

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).

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.