CARGO Therapeutics is engineering best-in-class CAR T-cell therapy to overcome resistance to cancer treatment and address barriers to access so that more patients may benefit from potentially curative therapies. CARGO is on a mission to outsmart cancer by advancing a new generation of best-in-class chimeric antigen receptor (CAR) T-cell therapies. Despite advances made by commercially available autologous CARs, these treatments are curative for fewer than half of all cancer patients. In addition, far too many patients are unable to access these potentially curative therapies due to other challenges, including manufacturing, supply constraints, slow turnaround time, and reimbursement hurdles. The team at CARGO is intensely focused on pursuing novel solutions to achieve better cancer treatment outcomes and experiences.
We are seeking a highly motivated individual to join our team as a Principal Scientist of Translational Medicine. In this role, you will collaborate closely with colleagues across multiple departments, including Translational Medicine, Clinical Operations, Clinical Development, Discovery Research, Process Sciences, Data Sciences, Regulatory, and Quality & Compliance to support development of novel CAR T therapeutics.
The successful candidate will be instrumental in designing and executing clinical pharmacology methods and clinical trial translational strategies for CARGO’s CAR T studies, as well as supporting reverse translational initiatives to inform understanding of patient outcomes, optimize our platform, and generate insights to enhance future pipeline candidates. Building and maintaining strong working relationships with key internal and external partners will be essential to ensure compliance, effective clinical trial conduct, and a comprehensive understanding of translational endpoints and methodologies.
Candidates should have relevant drug development experience in industry related to novel assay development, method qualification, assay troubleshooting, compliant SOP drafting, document management, data analysis, CRO oversight, and human clinical trial support.
The role is based in San Carlos, CA.
WHAT YOU’LL DO AT CARGO THERAPEUTICS
As a Principal Scientist within Translational Medicine you will support both internal and external scientific activities related to planned clinical studies of novel CAR T-cell products as well as future development of next generation cell therapy candidates. Within this position, you will also support the work of highly skilled and motivated internal laboratory scientists.
Key Responsibilities:
Support design and execution of clinical pharmacology and discovery biomarker strategies for clinical studies
Serve as Translational Medicine clinical program lead and oversee management of key technical contributors to enable delivery of clinical pharmacology data for investigational or registrational studies (PK/PD, ADA, biomarker safety endpoints, etc.)
Contribute to technology evaluation, development, qualification, and execution of novel methodologies for clinical biospecimen analysis
Identify and establish agreements with CROs and support the transfer and qualification of novel analytical methods
Write, review and edit technical documents including SOPs, method development/qualification reports, and study reports
Aid in the interpretation of clinical trial pharmacology and exploratory biomarker data
Work with internal and external Clinical Data Management and Data Science teams to qualify data acquisition
Support the preparation of data packages for publication, presentation and/or submission to regulatory authorities
Contribute to global regulatory requests including Investigational New Drug, Biologics License Application, and other regulatory activities
Drive external scientific discussions and engagement with key opinion leaders related to exploratory biomarker analysis
THE RIGHT STUFF: Required Experience & Qualifications
PhD or MS degree with demonstrated experience in cell therapy, immunology, cancer biology, or a closely related field, and 5-10 years of industry experience
Sound scientific track record as demonstrated through authorship of manuscripts and/or congress abstracts in the areas of cell therapy, immuno-oncology, immunology, or cancer biology
Understanding of CAR-T cell pharmacokinetic and pharmacodynamic approaches
Previous clinical trial experience in the setting of translational biology related to the investigation of novel agents
Experience with relevant technologies with an emphasis on flow cytometry, multiplexed immunoassay, NGS and PCR methods
Experience with clinical biospecimen testing, GCLP method development and qualification/validation requirements
Knowledge related to laboratory information management system (LIMS) and documentation of experiments in electronic lab notebook (ELN)
Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo, FACSDiva, and JMP
Demonstrated leadership, organizational and compliant record-keeping skills
Excellent interpersonal, verbal, and written communication skills are highly desirable in this collaborative work environment
Comfortable in a fast-paced environment and able to seamlessly adapt to changing priorities
Self-motivated and ambitious candidate with a strong work ethic
PAY RANGE
The combined pay range for this role is $144,000 - $198,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO’s programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic “cargo” designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO’s founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-tx.com/.
Join us to help make a difference!
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 required 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 Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics 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 because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.