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 Director, Data Management is responsible for leading data management activities, including Contract Research Organization (CRO) oversite for multiple clinical studies within a clinical development program. The Director, Data Management participates in the design and oversight of the database, to include database build and User Acceptance Testing. In addition, the Director, Data Management creates and provides reports on the progress and status of the on-going study data management activities and deliverables, ensuring assigned projects are delivered on track with high quality and accuracy.
Duties/Responsibilities:
- Serves as the Lead for all data management (DM) activities for clinical studies
- Plans, manages and performs data processing and management activities for assigned studies based on compliance with study specifications and the Company’s requirements/established timelines
- Oversees and collaborates with CRO’s Database Management function regarding all DM activities for clinical studies
- Reviews clinical study protocols, statistical analysis plans (SAP), and clinical study reports (CSR)
- Leads the development of the Data Management Plan (DMP)
- Leads the development of the study Data Validation Manual (DVM) as required
- Strong working knowledge of CDASH, SDTM or ADaM, and CDISC controlled Terminology
- Owns, governs and maintains designated GDO developed standards models (including but not limited to: CDASH, SDTM, Controlled Terminology, ADaM, TFLs and questionnaires)
- Leads the design and review of case report forms (CRFs/eCRFs) and completion guidelines
- Knowledge of at least one data management system and/or working knowledge of SAS
- Leads the design of an efficient clinical database using the Company’s standards and/or the CRO’s specifications, including the review of database design and function specifications to participate in User Acceptance Testing (UAT)
- Defines, validates, reviews and documents database edit checks to ensure electronically captured data are accurate and efficiently retrieved
- Writes clear queries on missing data and data points failing pre-defined range checks and/or logical checks; Leads efforts in developing and maintaining standard database integrity checks for common modules as well as for therapeutic/drug area specific modules
- Coordinates CRF/Data Clarification Form (DCF) tracking as needed
- Ensures medical coding (e.g., MedDRA, WHO Drug) is performed in an accurate and timely manner, as directed by the DMP
- Ensures accurate and timely resolutions of medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products
- Defines and monitors clinical trial data flow and quality control processes in accordance with Company Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and Good Data Management Practices (GDMP)
- Includes periodic assessment of standards content with respect to compliance and industry impacts
- Assists the Company, CROs and investigative sites with issuing and resolving data queries
- Ensures comprehensive data review and accurate (“clean”) locked clinical database
- Ensures timely execution of database lock per study and company timelines
- Maintains and prepares final archival of data management documentation relevant to the assigned clinical studies, and assists the Clinical Trial Team in assembling and archiving the documentation
- Prepares and presents DM topics to the Clinical Trial Team
- Provides operational and technical guidance and direction regarding DM activities
- Provides training to new Company and study site personnel on data management processes and procedures, data entry and review with electronic data capture systems, data flow and quality control processes
- Assists the Clinical Development Department with the medical and data quality review of clinical data by programming data visualization tools and/or generating patient profiles, tables, figures and listings
- Assists the Quality Assurance Department with quality control audits on assigned databases
- Validates and disseminates real-time study monitoring reports to Clinical Trial
- Other duties as assigned or required
Requirements:
- BA/BS in health and/or pharmaceutical sciences, computer and/or mathematical sciences, or relevant scientific disciplines; Advanced degree preferred
- 10+ years of progressive and relevant experience in pharmaceutical or biotechnology clinical trial data processing and management
- Significant experience managing clinical trial data management activities, applying data management concepts, clinical trial data processing techniques, and integrating them with the entire clinical trial operations
- Demonstrated experience with CRO and vendor management
- Significant experience with Medidata Rave
- Working knowledge of the clinical drug development process, FDA regulatory requirements, ICH/GCP guidelines, CDISC standards, and industry standard practices regarding DM
- Demonstrated ability to act/think strategically and see “the big picture”, all the while being hands on
- Demonstrated ability to handle high volumes of work in a fluid, dynamic, stressful and fast-paced environment
- Demonstrated ability to work simultaneously on multiple projects, and to deliver high-quality work according to tight timelines
- Demonstrates excellent communication (verbal/written/presentation) skills
- Demonstrates sound judgment, facilitation and interpersonal skills
- Detail-oriented with effective problem-solving and troubleshooting skills
- Process oriented with the ability to understand complex data and information
- Significant experience and understanding of medical terminology
- Significant experience using Microsoft Office Suite including Project, Excel, PowerPoint required; Experience with SharePoint or similar work management software/systems highly preferred.
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 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!
Base Salary: $185,000 - 225,000. Exact compensation may vary based on skills and experience.