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 key role in support of development initiatives through delivery of clinical pharmacology, central pathology, biomarker safety data, and development of next-generation companion diagnostics (CDx). Comprised of scientists across multiple disciplines, the TMG is responsible for delivering biology and translational data from human clinical trials that is needed to support cell therapy drug development from target identification through regulatory approval and commercialization. By leveraging both forward and reverse translation of clinical biomarker data, our goal is to help elucidate and guide the next wave of T cell enhancements and targets.
Please Join us to help make a difference!
Position Summary
We are seeking a highly motivated Scientist to join the TMG. The TMG Scientist will play a pivotal role in advancing CARGO’s engineered chimeric antigen receptor T-cell (CAR-T) pipeline and will support development of next generation cellular therapies. In this role, you will be expected to aid in the development and execution of novel methodologies to drive pharmacokinetic (PK), pharmacodynamic (PD), cell therapy product and patient tumor analyses in support of planned registrational and first-in-human (FIH) clinical trials. This position reports to the Vice President and Head of Translational Medicine.
What You’ll Do at CARGO
As a key contributor to clinical biomarker, diagnostic and future pipeline strategy, the TMG Scientist will be accountable for aiding in the development of novel sample analysis methodologies, help to guide/execute internal and external (CRO) biospecimen analysis, and work with computational biologists to analyze data in support of registrational and future FIH studies of CARGO’s cellular therapy products. The TMG Scientist will also play a key role in supporting cross-functional teams including Discovery Research, Process Sciences, Clinical Manufacturing, Clinical Biometrics, and Regulatory.
Key Responsibilities:
- Aid in the formulation of hypotheses and support experimental design and execution of studies related to the clinical development of CARGO’s investigational CAR-T cell products
- Guide development and execution of novel assays to monitor CAR-T pharmacokinetics and pharmacodynamics (PK/PD)
- Support development of novel product characterization assays by optimizing and qualifying multi-parametric flow cytometry methodologies
- Develop and perform cell-based functional assays to interrogate product phenotype and function
- Aid in the design, execution and interpretation of next generation sequencing experiments to interrogate patient apheresis, T cell product, tumor and bone marrow samples
- Support development of novel T-cell therapy based immunogenicity assays (ADA)
- Support internal and external (CRO) execution of clinical biospecimen sample analysis (PK/PD, tumor, drug product, ADA etc.)
- Successfully execute and document laboratory procedures and experiments in a GxP- “like” environment
- Support Clinical Study (CST) and Biomarker Operations Management (BOM) teams to ensure timely execution of clinical biospecimen analysis and delivery of key data required for registrational studies, IND submission or external collaborations
- Work with Clinical Data Management, Computational Biology and Clinical Biometrics teams to support data migration, analysis, and interpretation
- Support the development, qualification, and execution of novel assays for clinical biospecimen analysis
- Support the preparation of translational data packages for publication, presentation and/or submission to regulatory agencies
- Support regulatory requests including Investigational New Drug (IND), Biologics License Application (BLA) and Request for Information (RFI)
- Present data internally and at external meetings
Additional Qualifications:
- Prior industry experience and demonstrated scientific knowledge in the areas of cancer immunotherapy, immunology and enginerred cell therapy
- Experience with bioanalytical assay development and qualification in a GxP setting
- Experience working with engineered T cells, immunophenotyping (flow cytometry), functional assays (co-culture), and NGS-based approaches intended to profile the function of tumor and immune cells
- Hands-on experience in developing, qualifying and executing biospecimen analysis using quantitative PCR (qPCR), droplet digital (dd) PCR using a variety of sample types
- Multi-parametric flow cytometry experience
- Multi-parametric ELISA-based assay experience (MSD, Luminex, Ella)
- Experience performing T cell culture and functional assays utilizing cancer cell lines
- General computational biology skills would be advantageous
- Willingness to collaborate cross-functionally, excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced matrix-based work environment and able to adjust workload based upon corporate prioritzation
The Right Stuff
- Advanced scientific degree (i.e. PhD) and 2+ years of industry experience OR Master’s Degree and 4+ years of industry experience OR a Bachelor’s Degree and 7+ years of industry experience
- Experience in the development and qualification/ validation of biomarker/PD assays, implementation in clinical trials, and corresponding data analysis and interpretation
- 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.
