A Black Diamond client is seeking a Sr. Clinical Studies Scientist. This individual will be responsible for the management of clinical studies for new & improved projects for Flow Cytometry 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. The candidate prepares these protocols adhering to CLSI and FDA guidance documents. The ideal candidate is experienced in the field of clinical Flow Cytometry with good understanding of the disease states and applications of the technology in particular in the fields of leukemia and lymphoma, transplantation biology or immunotherapies. Candidate understands the laboratory environment and unmet clinical/customer needs.
- Experience with or sufficient knowledge of immunology, cell biology and good understanding of any of the following areas: leukemia and lymphoma clinical flow applications, (hematological malignancies), transplantation, immunotherapies, immune deficiencies.
- IVD (In-Vitro Diagnostics) experience.
- Managed Clinical Trials.
- Understanding of clinical studies and having minimally conducted research studies and study designs for hypothesis generation or clinical validation.
- Sufficient knowledge of immunology, cell biology, or other related field to understand customer needs and to enable interaction with principal investigators, medical professionals and key opinion leaders.
- 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
Remote: Sr. Clinical Studies Scientist (229355)