Associate Director, Biomarker Operations

Job Description

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.

 

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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.