Biomarker Operations Manager

About CARGO Therapeutics

At CARGO Therapeutics, upending the status quo is in our DNA. We combine a deep understanding of CAR T resistance with a vision of transforming peoples’ lives through the development of next generation cell therapies that provide deeper and more durable responses to a growing number of patients.

CARGO is an exciting biotechnology company founded by Crystal Mackall and Robbie Majzner to develop next generation CAR T cell therapies designed to achieve superior efficacy by pre-empting important drivers of drug resistance. Our lead program includes a differentiated and clinically validated CD22 CAR that is in clinical development for patients with B-cell malignancies. To help move this and other programs forward, CARGO has brought together a passionate and seasoned team to develop a focused portfolio strategy. Our team is based in San Mateo, California.

Translational Medicine Group at CARGO

The Translational Medicine Group (TMG) is integral to everything that we do at CARGO and sits at the nexus between Research, Clinical Development, Process Science and Manufacturing. To help guide development of next generation cellular therapy products, the TMG is focused on uncovering deep insights related to mechanisms of CAR T cell therapy resistance, immune system biology, and tumor biology. The TMG also plays a vital role in support of development initiatives through delivery of clinical pharmacology, central pathology, and biomarker safety data, as well as development of next-generation companion diagnostics. Comprised of scientists across multiple disciplines, the TMG is responsible for the biology and translational science necessary to support drug development from target identification through regulatory approval and commercialization by leveraging reverse translation of biomarker data to help uncover the next wave of T cell enhancements and targets.

Join us to help make a difference.

Position Summary

We are seeking a highly motivated Biomarker Operations Manager (BOM) to join the TMG. This position reports to the Vice President and Head of Translational Medicine. The BOM will have a pivotal role in planning and execution of clinical biospecimen collection, logistics, analysis, and data management. In this highly visible position, the BOM will work cross-functionally with team members in Clinical Operations, Data Management, Manufacturing, Quality Control, and with external vendors to drive biomarker assay development, execution, and key data deliverables. The successful candidate will have experience bridging both translational science and operations through cross functional partnerships, strategic planning and facilitating execution of key biomarker and diagnostic activities.

What You’ll Do at CARGO

As a key contributor to clinical biomarker, diagnostic and future pipeline strategy, the BOM will be accountable for vendor management/ oversight, implementation and execution of clinical sample collection, testing, and data delivery activities for both registrational and future first-in-human (FIH) studies of CARGO’s engineered cellular therapy products.

Key Responsibilities:

  • The BOM is a key member of the Study Management Team (SMT) and provides operational/ project management expertise related to biospecimen sampling, site and patient logistics, and vendor management to ensure deliverables to the SMT or TMG scientists
  • Participates in cross-functional study team meetings with members of Clinical Development, Regulatory, Research, Process Sciences, Quality Control and Clinical Manufacturing
  • Works effectively with procurement and TMG scientific leads to execute contracts and statements of work (SOW) to meet key corporate and program deliverables
  • Knowledgeable and can support supply chain activities related to CAR T cell manufacturing
  • In collaboration with Clinical Development and TMG members, creates and manages biomarker and diagnostic sampling plans, budget, timelines, risk assessments and quality metrics during startup, study conduct and closeout
  • The BOM role supports planning and coordinating operational and logistical activities required for the collection and delivery of clinical trial samples (Biomarker, PK and PD) for registrational and FIH studies
  • Provides support for writing and executing biomarker operations and companion diagnostics plans (if needed) in support of registrational and FIH studies. Supported activities may include scenario planning, forecasting of timelines, feasibility assessment, budget and resource forecasting (in collaboration with various cross-functional teams)
  • Ensure procedures and process for biospecimen sample collection, sample analysis and data delivery comply with ethics, quality standards, and informed consent for each clinical study
  • Support biospecimen collection strategy through presentations at Investigator Meetings and support authoring of study-related documents

Additional Responsibilities:

  • Support education of other team members through knowledge sharing
  • Onboard/train additional BOM staff
  • Communicate and follow-up on any relevant changes to biomarker operations planning which requires implementation across multiple programs
  • Clearly and effectively communicate budget, timelines and changes to stakeholders as appropriate
  • Provide biomarker operations expertise and strategy as the program portfolio expands
  • Works with scientific stakeholders to identify novel and innovative biospecimen collection strategy, processing techniques, and storage to ensure logistical feasibility for future programs

It will be critical for the qualified candidate to build strategic partnerships with CARGO colleagues and stakeholders across internal functional groups; in addition to also building relationships and/or establishing collaborations with scientific leaders, therapeutic area experts, academic partners, vendors, and health authorities.

The Right Stuff

Preferred Qualifications:

  • Life Science degree (BS or MS) in scientific, medical or healthcare area is required. A background in biology, immunology or a related scientific discipline is preferable.
  • 5+ years of work experience in a clinical development, pharmaceutical or biotech research and development organization
  • Experience in clinical sample collection, logistics, and operations is required
  • Experience in the development and qualification/ validation of biomarker/PD assays, implementation in clinical trials, and corresponding data analysis and interpretation
  • Experience managing multiple outside vendors
  • Familiarity with clinically relevant assay platforms such as flow cytometry, PCR, ELISA, NGS and primary cell isolation from blood and bone marrow samples
  • Understanding and experience with clinical trial research and GCLP regulations and compliance
  • Excellent written and verbal communication skills
  • Willingness to positively impact company culture and demonstrate flexibility in a fast-paced and evolving professional environment

EEO & Employment Eligibility

CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requires of applicable law.

CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at CARGO, and it applies regardless of whether the position is located at a CARGO site or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.