Associate Director, Biomarker Operations

Artiva Biotherapeutics•San Diego, CA

About The Position

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.

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
Time Management
Risk Management
Operations Management
Finance Business Planning
Implementing Plans
Analysis and Reporting
Negotiation
Honesty/Integrity
Communication skills
Self-starter
Forward thinking
Creative/imaginative
Confident
Self-controlled
Intuitive
Positive
Committed
Ambitious/driven
Agile
Collaborative
Transparent

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.