Senior Manager, Clinical Programs

Danaher•Vista, CA

2d•Remote

About The Position

The Senior Manager, Clinical Programs is a leadership role responsible for global oversight of clinical trial execution for Danaher Diagnostics, specifically supporting Leica Biosystems. The role leads a team of clinical study managers and drives strategic operational execution, regulatory compliance, and delivery of key milestones for critical clinical studies. It reports to the Director, Clinical Development, and is part of the Global Clinical Affairs team. The position is fully remote. The role provides strategic oversight for multiple studies across Digital Pathology, Immunohistochemistry (IHC) and In Situ Hybridization (ISH), Companion Diagnostics (CDx), and medical devices. It also oversees study teams, program timelines, budgets, resource allocation, site performance, and study quality, while collaborating with cross-functional partners and contributing to clinical operations processes and best practices.

Requirements

Bachelor’s degree in Life Sciences, Healthcare, or a related field and 7+ years of clinical research experience, including significant US and/or EU trial experience; or a Master’s or Doctoral degree and 5+ years of the same experience.
4+ years of direct leadership experience, including experience managing clinical study managers.
In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry for products intended for 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 scientific aspects of study protocols and reports.
Excellent written and verbal communication, leadership, and interpersonal skills for team management and cross-functional collaboration.

Nice To Haves

Experience designing studies for in vitro diagnostic (IVD) technologies, especially Digital Pathology and Immunohistochemistry (IHC) and In Situ Hybridization (ISH).
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
Professional certification in Clinical Research, such as SoCRA or ACRP.

Responsibilities

Provide strategic oversight and guidance for execution of multiple clinical studies within assigned programs.
Lead, mentor, and manage a team of clinical study managers, supporting professional development and high-quality study execution.
Ensure studies comply with ICH-GCP guidelines, regulatory requirements, standard operating procedures, and study protocols.
Manage program-level timelines, budgets, and resource allocation, and proactively identify and mitigate execution risks.
Collaborate with Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, Scientific Affairs, Biostatistics, and other cross-functional teams.
Oversee clinical trial site selection and management, ensuring performance meets contractual obligations and quality standards.
Contribute to the development and implementation of clinical operations processes and best practices to improve efficiency and compliance.