Senior Manager, Clinical Programs

Regulatory Toolkit; United States; Remote; USD 145,000 - 175,000; Full time

Benefits offered by this job

Remote work

Bonus potential

Comprehensive benefits

Job summary

Leica Biosystems, a Danaher operating company, seeks a Senior Manager, Clinical Programs to lead global clinical trial execution for diagnostics products. You will manage a team of clinical study managers, ensure regulatory compliance, and drive milestones across US/EU markets in a fully remote role.

Responsibilities include strategic oversight, cross-functional collaboration, and timelines/budgets management, aligned with ICH-GCP guidelines and SOPs.

Qualifications

• Bachelor’s degree in Life Sciences or related field with 7+ years of clinical research experience, or Master/PhD with 5+ years in US/EU trials.
• 4+ years direct leadership experience, including managing clinical study managers.
• Deep understanding of clinical study execution in diagnostics/medical devices/pharma for US/EU markets.

Responsibilities

• Provide strategic oversight for execution of multiple clinical studies in Digital Pathology, IHC & ISH, CDx, and Medical Device.
• Lead, mentor, and manage a team of clinical study managers.
• Ensure studies comply with ICH-GCP, regulatory requirements, and SOPs.
• Manage program timelines, budgets, and resource allocation; mitigate risks.
• Collaborate with Clinical Science, Clinical Operations, Regulatory Affairs, Data Management, and Biostatistics for study conduct and data integrity.
• Oversee site selection and management; ensure performance meets contractual obligations.
• Help develop clinical operations processes to improve efficiency and compliance.

Skills

Leadership

Communication

Team management

ICH-GCP

Clinical research

Education

Bachelor’s degree in Life Sciences, Healthcare, or related field

Master’s or Doctoral degree with 5+ years experience

Job description

Bring more to life.

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 lives—and 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.

Learn about the Danaher Business System which makes everything possible.

The Senior Manager, Clinical Programs is a leadership role is responsible for the oversight of clinical trial execution globally for Danaher Diagnostics. This role will specifically support Leica Biosystems, an operating company of Danaher Diagnostics. You will lead a team of clinical study managers, driving strategic operational execution, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in these vital markets.

This position reports to the Director, Clinical Development and is part of the Global Clinical Affairs team and will be 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, for Digital Pathology, and Immunohistochemistry (IHC) & In Situ Hybridization (ISH), Companion Diagnostics (CDx), and Medical Device.
• Lead, mentor, and manage a team of clinical study managers, fostering their professional development and ensuring high‑quality study execution standards.
• Ensure studies are conducted in accordance with ICH‑GCP guidelines, regulatory requirements, standard operating procedures (SOPs), and study protocols.
• Manage program‑level timelines, budgets, and resource allocation, proactively identifying and mitigating risks to study execution.
• Collaborate closely with cross‑functional teams (e.g., 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.

The essential requirements of the job include:

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 7+ years’ experience in clinical research, specifically with significant experience in US and/or EU trials, or a Masters or Doctoral degree with 5+ years of same experience.
• 4+ years direct leadership experience, including experience managing clinical study managers
• In-depth understanding of clinical study execution 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).

Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

At Leica Biosystems, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.

The annual salary range for this role is $145,000-175,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

For more information, visit www.danaher.com.

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.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].