Manager, Biomarker Operations

Manager, Biomarker Operations

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

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 timelines
• Working 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 audits
• Ensures timely collection kit preparation and sample testing database builds including review of required documentation
• Works with Clinical Operations and CRO to prepare for site activations including preparation of training materials
• Manages collection kit logistics, sample inventory, and sample testing at CROs; tracks and follows up on discrepancies and missing information
• Coordinates shipping and testing scheduling with central lab or 3rd party vendors
• Contributes to data transfer specifications review and implementation
• Assist the internal biomarker laboratory with sample shipping and receiving
• Contributes to translational logistics meetings

Requirements:

• 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 industry
• Demonstrated experience of managing biomarker sample operation of clinical trials, working with CROs to execute biomarker study plan.
• Excellent communication skills, verbal and written
• Understanding and experience with drug development and clinical trial process

Competencies:

• Time Management
• Risk Management
• Operations Management
• Finance
• Business Planning
• Implementing Plans
• Analysis and Reporting
• Negotiation

Attributes:

• Honesty/Integrity
• Communication skills
• Self-starter
• Forward thinking
• Creative/imaginative
• Confident
• Self-controlled
• Intuitive
• Positive
• Committed
• Ambitious/driven
• Agile
• Collaborative
• Transparent

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.

Base Salary: $130,000 - $142,000. Exact compensation may vary based on skills and experience.