Summary of the Position: Responsible for technical writing of clinical evaluation reports and literature reviews in the areas of HIV & leukemia and lymphoma to support upcoming EU registrations Flow Cytometry products following GCP and FDA requirements. The Senior Clinical Studies Scientist develops the test protocols(s) with guidance from Clinical Studies lead and based on the Regulatory strategy & Clinical Evidence Plan while adhering to CLSI and FDA guidance documents. You should understand the field of clinical Flow Cytometry and disease states: applications of the technology in particular in the fields of leukemia and lymphoma, HIV, transplantation biology or immunotherapies.
Essential Duties and Responsibilities (other duties may be assigned):
• Works under the general guidance of Staff Clinical Scientist or Clinical Studies lead for the project to prepare protocols for the external validation studies.
• Participates in the decision making for site selection and will visit and qualify new sites, make interim and site close-out visits as appropriate. Initiates clinical trials and ensures sites’ readiness. Ships materials and investigational devices and tracks device accountability.
• Will execute the site monitoring plan. Participates in investigators meetings and escalates protocol deviations and site issues to the Clinical Staff Scientist.
• Reviews data, ensures data quality, and supports data management personnel in data management for clinical trials. .
• Prepares data summaries, reports and presentations for design reviews. Works with Staff Clinical Scientist & Regulatory Affairs to ensure data outputs and templates are adequate for submission
• Prepares manuscripts for peer review, technical articles based on clinical trials and external studies.
• Interacts and consults with inter-department team members
Knowledge of immunology, cell biology and good understanding of any of the following areas: leukemia and lymphoma clinical flow applications, transplantation, immunotherapies, immune deficiencies.
• Understanding of clinical studies and having minimally conducted research studies and study designs for hypothesis generation or clinical validation
• Proven clinical technical writing skills to support regulatory submissions or clinical manuscripts. Well published in field of research.
• Presentation skills and excellent communication skills required
• Able to secure appropriate internal or external technical expertise required and coordinate efforts to resolve technical issues that may arise during clinical trials.
• Organizational, planning and detailed follow-up skills required.
• Demonstrated ability to be flexible and resourceful. Adaptable to changing environments
• Familiarity with preparation of Clinical Evidence Reports following MEDDEV and in compliance of EU Medical Device Regulations is a plus.
• Experience in clinical studies in IVD regulated diagnostics/medical device industry or experience with companion diagnostics and collaborations with pharma is a plus.
Education and Experience: Bachelor of Science (B.S.), Master of Science (M.S.) or Doctor of Philosophy (Ph.D.) in Immunology, Cell Biology, Biochemistry or a related field and a minimum of the following years of industry or relevant experience according to degree:
• Bachelor’s Degree 5+ years
• OR Master’s degree with 3+ years
• OR Doctoral degree with 0-2 years
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.