Clinical Trials Leader — Regulatory Strategy (Remote)

Danaher Corporation; United States; Remote; USD 130,000 - 150,000; Full time

Benefits offered by this job

Bonus/incentive pay

Health/dental/vision insurance

401(k)

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions and support regulatory submissions. The role is fully remote and pairs with the Senior Manager, Clinical Science in the Hematology and Urinalysis unit in Miami, FL.

You will design studies, liaise with regulators and external sites, collaborate cross-functionally with R&D, Medical Affairs, and Quality, and oversee study protocols and reports

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, or a related field with 9+ years of clinical research experience.
• In-depth understanding of clinical study design and methodology for US/EU markets in diagnostics/medical devices/pharmaceuticals.
• Excellent communication (written and verbal) and interpersonal skills for cross-functional collaboration.

Responsibilities

• Design clinical studies and evidence strategies supporting global regulatory submissions (FDA 510(k)/PMA, CE IVDR) across multiple diagnostic modalities.
• Act as a scientific and clinical liaison with regulatory bodies, key opinion leaders, and external sites to develop protocols, claims, and evidence plans.
• Partner cross functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs with product development and market access needs.
• Author and review clinical and regulatory documentation—including study reports, technical files, and publications to support product clearance and commercialization.
• Build strong internal and external collaborations, mentor junior scientists, and maintain expertise in evolving regulatory standards and diagnostic technologies.

Skills

Clinical trial design

Regulatory liaison

US/EU trial experience

Excellent communication

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related field

Master’s degree

Doctoral degree

Job description

Beckman Coulter Diagnostics, a Danaher operating company, is seeking a Principal Clinical Scientist to lead clinical trial strategies for US and EU regions and support regulatory submissions. The role is fully remote and pairs with the Senior Manager, Clinical Science in the Hematology and Urinalysis unit in Miami, FL.

You will design studies, liaise with regulators and external sites, collaborate cross-functionally with R&D, Medical Affairs, and Quality, and oversee study protocols and reports