Backed by 5AM Ventures.
About the role
The Sr. Clinical Trials Manager (Sr. CTM) is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Artiva Clinical Operations team.
What they're looking for
- BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
- At least seven years of experience in clinical trial management
- Experience in Cell Therapy, Autoimmune or Rare Disease is strongly preferred
- Past management of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
More about this role
Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.
AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.
Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading...
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