Danaher Life Sciences
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Senior Manager, Clinical Programs
role at
Danaher Life Sciences
Overview
The
Senior Manager, Clinical Programs
is a leadership role responsible for the oversight of global clinical trial execution for Danaher Diagnostics, specifically supporting Leica Biosystems. You will lead a team of clinical study managers, drive strategic operational execution, ensure regulatory compliance, and achieve key milestones for critical clinical studies in vital markets. The position reports to the Director, Clinical Development and is part of the Global Clinical Affairs team and is fully remote.
In This Role, You Will Have The Opportunity To
Provide strategic oversight and guidance for execution of multiple clinical studies within assigned programs, including Digital Pathology, Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx), and Medical Device.
Lead, mentor, and manage a team of clinical study managers, fostering professional development and ensuring high-quality study execution standards.
Ensure studies are conducted in accordance with ICH-GCP guidelines, regulatory requirements, SOPs, and study protocols.
Manage program-level timelines, budgets, and resource allocation, proactively identifying and mitigating risks to study execution.
Collaborate with cross-functional teams (Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, Scientific Affairs, Biostatistics) to ensure seamless study conduct and data integrity.
Oversee site selection and management for clinical trial activities, ensuring performance meets contractual obligations and quality standards.
Contribute to the development and implementation of clinical operations processes and best practices to enhance efficiency and compliance.
Qualifications
Bachelor’s degree in Life Sciences, Healthcare, or a related field with 7+ years’ experience in clinical research (significant US/EU trial experience); or Masters/Doctoral with 5+ years’ similar experience.
4+ years direct leadership experience, including managing clinical study managers.
In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with US/EU products.
Demonstrated ability to identify and solve complex issues in clinical trial conduct and interpretation.
Ability to critically review and interpret scientific and clinical trial data, and oversee study protocols and reports.
Excellent leadership and communication skills for managing a team and collaborating with cross-functional stakeholders.
Preferred Experience
Experience in study designs for in vitro diagnostic technologies (IVD), specifically Digital Pathology and IHC/ISH.
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
Professional certification in Clinical Research (e.g., SoCRA, ACRP).
Leica Biosystems, a Danaher operating company, offers comprehensive benefit programs and supportive policies, including flexible remote work for eligible roles. The annual salary range for this role is $145,000-175,000, with eligibility for bonus/incentive pay. We offer a comprehensive benefits package including paid time off and medical/dental/vision insurance. Note: compensation details may change; bonuses and benefits are earned or provided at the company’s discretion in accordance with applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. U.S. EEO posters are available here. We comply with disability laws and provide reasonable accommodations for applicants and employees with disabilities. For accommodations during the application or interview process, contact: 1-202-419-7762 or applyassistance@danaher.com.
For more information, visit www.danaher.com.
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Senior Manager, Clinical Programs
role at
Danaher Life Sciences
Overview
The
Senior Manager, Clinical Programs
is a leadership role responsible for the oversight of global clinical trial execution for Danaher Diagnostics, specifically supporting Leica Biosystems. You will lead a team of clinical study managers, drive strategic operational execution, ensure regulatory compliance, and achieve key milestones for critical clinical studies in vital markets. The position reports to the Director, Clinical Development and is part of the Global Clinical Affairs team and is fully remote.
In This Role, You Will Have The Opportunity To
Provide strategic oversight and guidance for execution of multiple clinical studies within assigned programs, including Digital Pathology, Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx), and Medical Device.
Lead, mentor, and manage a team of clinical study managers, fostering professional development and ensuring high-quality study execution standards.
Ensure studies are conducted in accordance with ICH-GCP guidelines, regulatory requirements, SOPs, and study protocols.
Manage program-level timelines, budgets, and resource allocation, proactively identifying and mitigating risks to study execution.
Collaborate with cross-functional teams (Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, Scientific Affairs, Biostatistics) to ensure seamless study conduct and data integrity.
Oversee site selection and management for clinical trial activities, ensuring performance meets contractual obligations and quality standards.
Contribute to the development and implementation of clinical operations processes and best practices to enhance efficiency and compliance.
Qualifications
Bachelor’s degree in Life Sciences, Healthcare, or a related field with 7+ years’ experience in clinical research (significant US/EU trial experience); or Masters/Doctoral with 5+ years’ similar experience.
4+ years direct leadership experience, including managing clinical study managers.
In-depth understanding of clinical study execution in the diagnostics, medical device, or pharmaceutical industry with US/EU products.
Demonstrated ability to identify and solve complex issues in clinical trial conduct and interpretation.
Ability to critically review and interpret scientific and clinical trial data, and oversee study protocols and reports.
Excellent leadership and communication skills for managing a team and collaborating with cross-functional stakeholders.
Preferred Experience
Experience in study designs for in vitro diagnostic technologies (IVD), specifically Digital Pathology and IHC/ISH.
Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs.
Professional certification in Clinical Research (e.g., SoCRA, ACRP).
Leica Biosystems, a Danaher operating company, offers comprehensive benefit programs and supportive policies, including flexible remote work for eligible roles. The annual salary range for this role is $145,000-175,000, with eligibility for bonus/incentive pay. We offer a comprehensive benefits package including paid time off and medical/dental/vision insurance. Note: compensation details may change; bonuses and benefits are earned or provided at the company’s discretion in accordance with applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. U.S. EEO posters are available here. We comply with disability laws and provide reasonable accommodations for applicants and employees with disabilities. For accommodations during the application or interview process, contact: 1-202-419-7762 or applyassistance@danaher.com.
For more information, visit www.danaher.com.
#J-18808-Ljbffr