Manager, Biomarker Operations
Artiva Biotherapeutics
San Diego, CA
Business Management / Project / Planning, Manufacturing / Production
About Artiva:
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 healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.
For more information, visit www.artivabio.com.
Job Summary:
Reporting to the Senior Manager, Biomarker Operations, the Manager, Biomarker Operations is responsible for managing operational aspects of the clinical biomarker projects. This position will be responsible for managing the biomarker operation of Artiva’s clinical studies by coordinating sample-related operations with Clinical Operations, contract executions, and communication between the Translational Science group with external contract research organizations (CRO) and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial process is a prerequisite for this position.
Duties/Responsibilities:
Oversee day-to-day biomarker operations of Artiva’s clinical trials including but not limited to execution of biomarker operations with external vendors, ensuring CROs meet all key deliverables and timelinesWorking closely with the translational leads, manages documentation and performance of biomarker assays conducted at CROs, ensures timely delivery of high-quality biomarker data, and supports CRO auditsEnsures timely collection kit preparation and sample testing database builds including review of required documentationWorks with Clinical Operations and CRO to prepare for site activations including preparation of training materialsManages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing informationCoordinates shipping and testing scheduling with central lab or 3rd party vendorsContributes to data transfer specifications review and implementationAssist the internal biomarker laboratory with sample shipping and receivingContributes to translational logistics meetings
Requirements:
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, and efficient. Excellent communication, project management and interpersonal skills. Able to develop important relationships with key internal stakeholders and external entities.
Bachelor’s or Master's degree in biology, immunology, or related fields and/or project management experience is required with a minimum of 6 - 8 years’ experience within the biotechnology or pharmaceutical industryDemonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan.Excellent communication skills, verbal and writtenUnderstanding and experience with drug development and clinical trial process
Competencies
Time ManagementRisk ManagementOperations ManagementFinanceBusiness PlanningImplementing PlansAnalysis and ReportingNegotiation
Attributes
Honesty/IntegrityCommunication skillsSelf-starterForward thinkingCreative/imaginativeConfidentSelf-controlledIntuitivePositiveCommittedAmbitious/drivenAgileCollaborativeTransparent
In addition to a great culture, we offer:
A beautiful facility An entrepreneurial, highly collaborative, and innovative environmentComprehensive benefits, including:Medical, Dental, and VisionGroup Life InsuranceLong Term Disability (LTD)401(k) Retirement PlanEmployee Assistance Program (EAP)Flexible Spending Account (FSA)Paid Time Off (PTO)Company paid holidays, including the year-end holiday weekOur recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.
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 healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.
For more information, visit www.artivabio.com.
Job Summary:
Reporting to the Senior Manager, Biomarker Operations, the Manager, Biomarker Operations is responsible for managing operational aspects of the clinical biomarker projects. This position will be responsible for managing the biomarker operation of Artiva’s clinical studies by coordinating sample-related operations with Clinical Operations, contract executions, and communication between the Translational Science group with external contract research organizations (CRO) and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial process is a prerequisite for this position.
Duties/Responsibilities:
Oversee day-to-day biomarker operations of Artiva’s clinical trials including but not limited to execution of biomarker operations with external vendors, ensuring CROs meet all key deliverables and timelinesWorking closely with the translational leads, manages documentation and performance of biomarker assays conducted at CROs, ensures timely delivery of high-quality biomarker data, and supports CRO auditsEnsures timely collection kit preparation and sample testing database builds including review of required documentationWorks with Clinical Operations and CRO to prepare for site activations including preparation of training materialsManages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing informationCoordinates shipping and testing scheduling with central lab or 3rd party vendorsContributes to data transfer specifications review and implementationAssist the internal biomarker laboratory with sample shipping and receivingContributes to translational logistics meetings
Requirements:
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, and efficient. Excellent communication, project management and interpersonal skills. Able to develop important relationships with key internal stakeholders and external entities.
Bachelor’s or Master's degree in biology, immunology, or related fields and/or project management experience is required with a minimum of 6 - 8 years’ experience within the biotechnology or pharmaceutical industryDemonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan.Excellent communication skills, verbal and writtenUnderstanding and experience with drug development and clinical trial process
Competencies
Time ManagementRisk ManagementOperations ManagementFinanceBusiness PlanningImplementing PlansAnalysis and ReportingNegotiation
Attributes
Honesty/IntegrityCommunication skillsSelf-starterForward thinkingCreative/imaginativeConfidentSelf-controlledIntuitivePositiveCommittedAmbitious/drivenAgileCollaborativeTransparent
In addition to a great culture, we offer:
A beautiful facility An entrepreneurial, highly collaborative, and innovative environmentComprehensive benefits, including:Medical, Dental, and VisionGroup Life InsuranceLong Term Disability (LTD)401(k) Retirement PlanEmployee Assistance Program (EAP)Flexible Spending Account (FSA)Paid Time Off (PTO)Company paid holidays, including the year-end holiday weekOur recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.
About the company
Company website•Biotechnology Research and Pharmaceutical Manufacturing
Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.