Remote Global Senior Manager, Clinical Science

Regulatory Jobs; United States; Remote; USD 170,000 - 190,000; Full time

Benefits offered by this job

Bonus/incentive pay

Medical/dental/vision insurance

401(k)

Job summary

Leica Biosystems, a Danaher operating company, seeks a Sr. Manager, Clinical Science (Global - Remote) to lead clinical study design and strategies across US and EU markets.

You will manage a team of clinical scientists, ensure regulatory alignment, and drive milestones in pivotal trials for diagnostics and medical devices. You will collaborate with R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, and external partners to translate clinical insights into product development and

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or related field with 12+ years’ experience in clinical research.
• 4+ years direct leadership experience, including managing clinical research scientists.
• Deep understanding of clinical study design and methodology in diagnostics, medical device, or pharmaceutical industry.
• Ability to identify and solve complex issues in clinical trial conduct and scientific interpretation.
• Excellent leadership, communication and interpersonal skills for managing a team and cross-functional collaboration.

Responsibilities

• Oversee scientific planning and design of clinical studies for Digital Pathology, IHC & ISH, CDx and Medical Device.
• Ensure rigor and accuracy of clinical protocols, CRFs, study reports, and other documentation.
• Serve as a key scientific liaison with R&D, Regulatory, Medical Affairs and other teams to integrate insights into development and commercialization.
• Collaborate with Regulatory Affairs to support submissions and interactions with agencies.
• Build, lead and mentor a high-performing team of clinical scientists and foster their development.
• Establish and maintain relationships with internal cross-functional teams and external CROs, investigators and key opinion leaders.
• Manage analysis of clinical study data and guide dissemination through publications and internal reports.

Skills

Leadership experience

Communication skills

Interpersonal skills

Regulatory submissions

Education

Bachelor's degree in Life Sciences

Master's/ Doctoral in related field

Job description

Leica Biosystems, a Danaher operating company, seeks a Sr. Manager, Clinical Science (Global - Remote) to lead clinical study design and strategies across US and EU markets.

You will manage a team of clinical scientists, ensure regulatory alignment, and drive milestones in pivotal trials for diagnostics and medical devices. You will collaborate with R&D, Regulatory Affairs, Medical Affairs, Quality Assurance, and external partners to translate clinical insights into product development and