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About Artiva:
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary:
The Sr. Clinical Trials Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing the conduct of clinical trials. The Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables. San Diego location preferred. The remote option depends on experience level.
Duties/Responsibilities:
• Developing and maintaining good working relationships with CRO, investigators and study staff.
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
• Ensure timely response to queries and monitoring discrepancies.
• Assist with third-party vendor training on protocols and practices. Coordinate the logistics of Artiva product readiness with sites and internally within Artiva. Work cross-functionally with product manufacturing, QA and supply chain management, to coordinate site training, product delivery, supply management to ensure readiness and product availability prior to patient treatment.
• Tracking and reporting on current progress of the study including site activation, patient enrollment, monitoring visits and data submission backlogs.
• Support the investigational product (IP) and non-IP study drug accountability and reconciliation process.
• Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
• Perform clinical data review of data listings and summary tables, including query generation.
• Perform initial review of CRO and other third-party study vendor invoices for correctness.
• Plan and conduct investigator meetings as directed.
• Review key study quality metrics (e.g. patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
• Review and/or approve IP release packages.
• Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
• Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.
• Ensure audit-ready condition of clinical trial documentation including central clinical files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assist in the planning of regulatory or ethics committee activities, as appropriate.
• Collaborate with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
• Prepare and/or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
• Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
• Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.
• Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
Requirements:
• Undergraduate degree in life sciences or relevant work experience. Graduate degree preferred.
• Therapeutic experience in autoimmunity is strongly preferred.
• Five or more years’ experience managing clinical trials as the sponsor is preferred; prior working experience at a site or in a CRO is a plus.
• Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
• Experience monitoring sites and conducting other site management activities.
• Ability to work in a fast-paced environment and flexibility
• Proven experience in early phase clinical trials.
• Strong site management and CRO management skills required.
• Proven communicator, both oral and written.
• Travel up to 30%
.
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative – pushing into new frontiers for patient benefit. We are transparent – believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
• Medical, Dental, and Vision
• Group Life Insurance
• Long Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company paid holidays, including the year-end holiday week
• Our 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!
Artiva Biotherapeutics is an equal employment opportunity employer.
Base Salary: $155,000 – $165,000. Exact compensation may vary based on skills and experience.
