Senior Manager, Clinical Programs
Danaher Corporation
Summary
The Senior Manager, Clinical Programs is a leadership role 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.
Job description
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).
Requirements
- 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
- 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
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.