Associate Director, Biomarker Operations

Artiva Biotherapeutics Inc.; San Diego (CA); On-site; USD 153,000 - 207,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

401(k) Retirement Plan

Paid Time Off (PTO)

Bonus.ly recognition program

Job summary

Artiva Biotherapeutics Inc. in San Diego, CA, is seeking an Associate Director, Biomarker Operations to lead the biomarker operations function across clinical trials.

You will coordinate study start-up activities with the central lab, manage vendor contracts and budgets, and ensure timely delivery of high-quality biomarker data in partnership with Clinical Operations and Translational Science. You will lead a team of biomarker operations professionals, oversee sample tracking, kit preparation,

Qualifications

• Must thrive in a fast-paced, innovative environment with flexible, proactive, and efficient work style.
• Bachelor’s or Master’s degree in biology, immunology, or related fields and/or project management experience is required.
• Minimum 6–10 years of experience in biotechnology or pharmaceutical industry.
• Demonstrated experience managing biomarker sample operations with central lab and CROs.
• Excellent verbal and written communication skills, interpersonal abilities, and stakeholder management.

Responsibilities

• Define strategy for biomarker operations across Artiva’s clinical trials.
• Oversee day-to-day biomarker operations with external vendors; ensure deliverables and timelines.
• Lead a team of biomarker operations professionals.
• Coordinate documentation and performance tracking of biomarker assays at central labs/CROs.
• Ensure timely kit preparation and sample testing database builds; review documentation.
• Collaborate with Clinical Operations and central lab for site activation readiness; prepare training materials.
• Manage kit logistics, sample inventory, and sample testing at central lab; resolve discrepancies.
• Coordinate shipping and testing scheduling with central lab and CROs.
• Contribute to data transfer specs review and implementation.
• Oversee central lab budgeting and contract oversight; liaise with Finance/Procurement.
• Support timely invoice submissions and contract requests; engage Legal as needed.
• Attend translational logistics meetings and represent Biomarker Operations in study teams.

Skills

Project management

Communication

Interpersonal skills

Education

Bachelor’s or Master’s in biology/immunology/related fields

Job description

About Artiva:

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.

For more information, visit www.artivabio.com.

Job Summary:

Reporting to the SVP, Research & Early Development, the Associate Director, Biomarker Operations is responsible for overseeing the operational aspects of the clinical/translational biomarker projects. This position will lead the biomarker operations function to support Artiva’s clinical studies by interfacing with the central lab for study start up, kit preparation and deployment, sample tracking, contracting and budgets. They will work closely with Clinical Operations on coordination of sample-related operations and with the Translational Science group to facilitate communication between the central lab, 3rd party CROs and internal lab personnel. The successful candidate will have strong communication and project management skills. Understanding and experience with drug development and clinical trial processes is a prerequisite for this position

Duties/Responsibilities:

• Defines the strategy for biomarker operations execution by establishing best practices for application across Artiva’s clinical trials.
• Accountable for the day-to-day biomarker operations of Artiva’s clinical trials including execution of biomarker operations with external vendors and ensuring central lab and CROs meet all key deliverables and timelines.
• Leads a team of biomarker operations professionals to support current and planned clinical trials.
• Working closely with the translational leads, manages documentation and tracks performance of biomarker assays conducted at the central lab or 3rd party 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 central lab to prepare for site activations including preparation of training materials.
• Manages collection kit logistics, sample inventory, and sample testing at central lab; tracks and follows up on discrepancies and missing information.
• Coordinates shipping and testing scheduling with central lab and 3rd party vendors.
• Contributes to data transfer specifications review and implementation
• Responsible for central lab budget planning and contract oversight.
• Collaborates with Finance for budget tracking and follow up with external vendors to ensure timely invoice submissions.
• Works with procurement, finance and legal departments to ensure timely completion of contract requests.
• Responsible for translational logistics meetings.
• Attends study team meetings as Biomarker Operations representative.

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 - 10 years of experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience managing biomarker sample operation of clinical trials, working with central lab and CROs to execute biomarker study plan.
• Excellent communication skills, verbal and
• Understanding and experience with drug development and clinical trial

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.

If all this speaks to you, come join us on our journey!

Base Salary: $175,000 -185,000. Exact compensation may vary based on skills and experience.